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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01039688




Trial ID
NCT01039688
Ethics application status
Date submitted
23/12/2009
Date registered
23/12/2009
Date last updated
8/03/2018

Titles & IDs
Public title
Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Scientific title
Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
2009-016987-34
Secondary ID [2] 0 0
A3921069
Universal Trial Number (UTN)
Trial acronym
ORAL1069
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - Disease-modifying antirheumatic drug

Experimental: 5 mg BID CP-690,550 -

Experimental: 10 mg BID CP-690,550 -

Active Comparator: methotrexate -


Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months

Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months

Treatment: Drugs: Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Total Sharp Score (mTSS) at Month 6 - mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Change From Baseline at Month 6 in mTSS - mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Timepoint [2] 0 0
Month 6
Primary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 - ACR70 response: greater than or equal to (=) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).
Timepoint [3] 0 0
Month 6
Primary outcome [4] 0 0
Absolute Blood Pressure (BP) Values (mmHg) - BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Timepoint [4] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Primary outcome [5] 0 0
Change From Baseline in BP Values (mmHg) - BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Timepoint [5] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary outcome [1] 0 0
mTSS Score at Baseline, Months 12 and 24 - mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Timepoint [1] 0 0
Baseline, Months 12 and 24
Secondary outcome [2] 0 0
Change From Baseline in mTSS Score at Months 12 and 24 - mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Timepoint [2] 0 0
Months 12 and 24
Secondary outcome [3] 0 0
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 - mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (=)0.5 in mTSS is considered to be no progression in the mTSS.
Timepoint [3] 0 0
Months 6, 12, and 24
Secondary outcome [4] 0 0
Percentage of Participants With no Worsening in Erosion Score (Increase =0.5) at Months 6, 12, and 24 - Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of =0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Timepoint [4] 0 0
Months 6, 12, and 24
Secondary outcome [5] 0 0
Erosion Scores - Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Timepoint [5] 0 0
Baseline, Months 6, 12, and 24
Secondary outcome [6] 0 0
JSN Scores - JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Timepoint [6] 0 0
Baseline, Months 6, 12, and 24
Secondary outcome [7] 0 0
Change From Baseline in Erosion Scores - Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Timepoint [7] 0 0
Months 6, 12, and 24
Secondary outcome [8] 0 0
Change From Baseline in JSN Scores - JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Timepoint [8] 0 0
Months 6, 12, and 24
Secondary outcome [9] 0 0
Percentage of Participants Achieving an ACR70 Response - ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [9] 0 0
Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving an ACR20 Response - ACR20 response: =20% improvement in TJC or SJC and =20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [10] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [11] 0 0
Percentage of Participants Achieving an ACR50 Response - ACR50 response: =50% improvement in TJC or SJC and =50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [11] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [12] 0 0
Tender Joints Count (TJC) - Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Timepoint [12] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [13] 0 0
Change From Baseline in TJC - Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Timepoint [13] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [14] 0 0
Swollen Joints Count (SJC) - Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Timepoint [14] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [15] 0 0
Change From Baseline in SJC - Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Timepoint [15] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [16] 0 0
Patient Assessment of Arthritis Pain - Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Timepoint [16] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [17] 0 0
Change From Baseline in Patient Assessment of Arthritis Pain - Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Timepoint [17] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [18] 0 0
Physician Global Assessment of Arthritis - Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Timepoint [18] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [19] 0 0
Change From Baseline in Physician Global Assessment of Arthritis - Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Timepoint [19] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [20] 0 0
Patient Global Assessment of Arthritis - Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Timepoint [20] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [21] 0 0
Change From Baseline in Patient Global Assessment of Arthritis - Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Timepoint [21] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [22] 0 0
C-Reactive Protein - CRP measured in milligrams per liter (mg/L)
Timepoint [22] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [23] 0 0
Change From Baseline in CRP - Change from Baseline in CRP measured in mg/L.
Timepoint [23] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [24] 0 0
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.
Timepoint [24] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [25] 0 0
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Timepoint [25] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [26] 0 0
Change From Baseline in DAS28-3(CRP) - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Timepoint [26] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [27] 0 0
Change From Baseline in DAS28-4(ESR) - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Timepoint [27] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [28] 0 0
Percentage of Participants With DAS28-3(CRP) =3.2 - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Timepoint [28] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [29] 0 0
Percentage of Participants With DAS28-4(ESR) =3.2 - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Timepoint [29] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [30] 0 0
Percentage of Participants With DAS28-3(CRP) <2.6 - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Timepoint [30] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [31] 0 0
Percentage of Participants With DAS28-4(ESR) <2.6 - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Timepoint [31] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [32] 0 0
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Timepoint [32] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [33] 0 0
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Timepoint [33] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [34] 0 0
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months - ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [34] 0 0
Months 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [35] 0 0
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits - ACR20 response: =20% improvement in TJC or SJC and =20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [35] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [36] 0 0
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits - ACR50 response: =50% improvement in TJC or SJC and =50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [36] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [37] 0 0
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits - ACR70 response: =70% improvement in TJC or SJC and =70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Timepoint [37] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [38] 0 0
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits - DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.
Timepoint [38] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [39] 0 0
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits - DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) =3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.
Timepoint [39] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [40] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) - HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [40] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [41] 0 0
Change From Baseline in HAQ-DI Score - HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [41] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [42] 0 0
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score - HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [42] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [43] 0 0
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score - HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [43] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [44] 0 0
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI - HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [44] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [45] 0 0
Short Form 36 (SF-36) Mental Component Score - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Timepoint [45] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [46] 0 0
SF-36 Physical Component Score - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Timepoint [46] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [47] 0 0
Change From Baseline in SF-36 Mental Component Score - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Timepoint [47] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [48] 0 0
Change From Baseline in SF-36 Physical Component Score - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Timepoint [48] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [49] 0 0
SF-36 Domain Scores - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Timepoint [49] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [50] 0 0
Change From Baseline in SF-36 Domain Scores - SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Timepoint [50] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [51] 0 0
Work Limitation Questionnaire (WLQ) Score - WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Timepoint [51] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [52] 0 0
Change From Baseline in WLQ Scores - WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Timepoint [52] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [53] 0 0
WLQ Work Loss Index Score - WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
Timepoint [53] 0 0
Baseline and Months 3, 6, and 12
Secondary outcome [54] 0 0
Change From Baseline in WLQ Work Loss Index Score - WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).
Timepoint [54] 0 0
Months 3, 6, 12, 15, 18, 21, and 24
Secondary outcome [55] 0 0
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Timepoint [55] 0 0
Baseline and Months 3, 6, 12, 18, and 24
Secondary outcome [56] 0 0
Change From Baseline in EQ-5D Health State Profile Utility Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Timepoint [56] 0 0
Months 3, 6, 12, 18, and 24
Secondary outcome [57] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 - Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Timepoint [57] 0 0
Baseline and Months 3 and 6
Secondary outcome [58] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 - RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Timepoint [58] 0 0
Months 12, 18, and 24
Secondary outcome [59] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [59] 0 0
Baseline and Months 3 and 6
Secondary outcome [60] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [60] 0 0
Months 12, 18, and 24
Secondary outcome [61] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [61] 0 0
Baseline and Months 3 and 6
Secondary outcome [62] 0 0
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [62] 0 0
Months 12, 18, and 24
Secondary outcome [63] 0 0
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 - RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Timepoint [63] 0 0
Baseline and Months 3 and 6
Secondary outcome [64] 0 0
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Timepoint [64] 0 0
Months 12, 18, and 24
Secondary outcome [65] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU - Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Timepoint [65] 0 0
Baseline, Months 3, 6, 12, 18, and 24
Secondary outcome [66] 0 0
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 - RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Timepoint [66] 0 0
Months 3 and 6
Secondary outcome [67] 0 0
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 - RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Timepoint [67] 0 0
Months 12, 18, and 24
Secondary outcome [68] 0 0
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [68] 0 0
Months 3 and 6
Secondary outcome [69] 0 0
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [69] 0 0
Months 12, 18, and 24
Secondary outcome [70] 0 0
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [70] 0 0
Months 3 and 6
Secondary outcome [71] 0 0
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [71] 0 0
Months 12, 18, and 24
Secondary outcome [72] 0 0
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Timepoint [72] 0 0
Months 3 and 6
Secondary outcome [73] 0 0
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 - RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Timepoint [73] 0 0
Months 12, 18, and 24
Secondary outcome [74] 0 0
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU - Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Timepoint [74] 0 0
Months 3, 6, 12, 18, and 24
Secondary outcome [75] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 - Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Timepoint [75] 0 0
Baseline and Months 1, 2, and 3
Secondary outcome [76] 0 0
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS - MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
Timepoint [76] 0 0
Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [77] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 - Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Timepoint [77] 0 0
Months 6, 12, 18, and 24
Secondary outcome [78] 0 0
Change From Baseline in MOS-SS at Months 1, 2, and 3 - Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Timepoint [78] 0 0
Months 1, 2, and 3
Secondary outcome [79] 0 0
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 - Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.
Timepoint [79] 0 0
Months 6, 12, 18, and 24
Secondary outcome [80] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale - FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Timepoint [80] 0 0
Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [81] 0 0
Change From Baseline in FACIT-Fatigue Scale - FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Timepoint [81] 0 0
Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [82] 0 0
Change From Baseline in Heart Rate
Timepoint [82] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [83] 0 0
Change From Baseline in Temperature
Timepoint [83] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Eligibility
Key inclusion criteria
- Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated
with methotrexate.

- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

- Active disease as defined by both >=6 tender or painful joints on motion and >= 6
joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a
C-reactive protein (CRP) concentration > 7 mg/dL
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
<100 x 109/L

- History of any other rheumatic autoimmune disease other than Sjogren's syndrome

- No malignancy or history of malignancy

- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug

- No chronic liver disease, recent or active hepatitis or other contraindication to
methotrexate therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital, Department of Rheumatology - Woodville
Recruitment hospital [3] 0 0
Emeritus Research - Malvern East
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Brazil
State/province [22] 0 0
GO
Country [23] 0 0
Brazil
State/province [23] 0 0
PR
Country [24] 0 0
Brazil
State/province [24] 0 0
RS
Country [25] 0 0
Brazil
State/province [25] 0 0
SP
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio de Janeiro
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Ruse
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Veliko Tarnovo
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Chile
State/province [35] 0 0
IX Region
Country [36] 0 0
Chile
State/province [36] 0 0
RM
Country [37] 0 0
Chile
State/province [37] 0 0
V Region
Country [38] 0 0
Chile
State/province [38] 0 0
Rancagua
Country [39] 0 0
Colombia
State/province [39] 0 0
Atlantico
Country [40] 0 0
Colombia
State/province [40] 0 0
Cundinamarca
Country [41] 0 0
Colombia
State/province [41] 0 0
Santander
Country [42] 0 0
Costa Rica
State/province [42] 0 0
Cartago
Country [43] 0 0
Costa Rica
State/province [43] 0 0
San Jose
Country [44] 0 0
Czechia
State/province [44] 0 0
Brno - Zidenice
Country [45] 0 0
Czechia
State/province [45] 0 0
Brno
Country [46] 0 0
Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czechia
State/province [47] 0 0
Ostrava-Poruba
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha 2
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 4
Country [50] 0 0
Dominican Republic
State/province [50] 0 0
Santo Domingo
Country [51] 0 0
Germany
State/province [51] 0 0
Aachen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Erlangen
Country [54] 0 0
Germany
State/province [54] 0 0
Halle
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Nuernberg
Country [57] 0 0
Germany
State/province [57] 0 0
Ratingen
Country [58] 0 0
Germany
State/province [58] 0 0
Rheine
Country [59] 0 0
Hungary
State/province [59] 0 0
Balatonfüred
Country [60] 0 0
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Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to
methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
study will also compare the safety of CP-690,550 with methotrexate.
Trial website
https://clinicaltrials.gov/show/NCT01039688
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries