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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00883753




Registration number
NCT00883753
Ethics application status
Date submitted
17/04/2009
Date registered
20/04/2009
Date last updated
6/08/2014

Titles & IDs
Public title
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
Scientific title
An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.
Secondary ID [1] 0 0
2008-006924-68
Secondary ID [2] 0 0
MA22460
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 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 - tocilizumab [RoActemra/Actemra]

Experimental: tocilizumab - Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment method [1] 0 0
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.
Timepoint [1] 0 0
108 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events Leading to Withdraw
Assessment method [1] 0 0
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
Timepoint [1] 0 0
108 Weeks
Secondary outcome [2] 0 0
Time to Withdrawal Due to an Adverse Event (AE)
Assessment method [2] 0 0
Time to withdrawal was defined as the number of days from Core Study Day 1 to the first date of onset of the AE leading to discontinuation of tocilizumab.
Timepoint [2] 0 0
108 Weeks
Secondary outcome [3] 0 0
Percentage of Participants With Discontinuation of Treatment Due to Any Cause
Assessment method [3] 0 0
Percentage of participants who discontinued treatment with tocilizumab for any reason.
Timepoint [3] 0 0
108 Weeks
Secondary outcome [4] 0 0
Time to Discontinuation of Tocilizumab Treatment for Any Cause
Assessment method [4] 0 0
Time in days from start of the Core Study Day 1 to discontinuation of tocilizumab for any reason.
Timepoint [4] 0 0
108 Weeks
Secondary outcome [5] 0 0
Percentage of Participants With Marked Lipid Abnormalities
Assessment method [5] 0 0
Fasting blood samples were collected for Lipids: Cholesterol, Triglyceride, High-density lipoprotein (HDL) Cholesterol, Low-density lipoprotein (LDL) Cholesterol every 12 weeks and at follow-up in the Extension study and were sent to a central laboratory for analysis. Lipid abnormalities were defined as a High Cholesterol, High Triglyceride, Low HDL Cholesterol and a High LDL Cholesterol that occurred at any time in the extension study.
Timepoint [5] 0 0
108 Weeks
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events (AEs) of Special Interest
Assessment method [6] 0 0
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Adverse Events of special interest for this study were: Infections (preferred term in the infection adverse event group term), Serious Infections (an infection that qualified as Serious Adverse Event), Infusion Reactions (occurred during infusion or within 24 hours of infusion), Major Cardiac AE (Myocardial Infarction/ Acute Coronary Syndrome), Stroke or Death.
Timepoint [6] 0 0
108 Weeks
Secondary outcome [7] 0 0
Percentage of Participants With ALT Elevations > 3*ULN
Assessment method [7] 0 0
Blood samples were collected for the Liver Function Test: Alanine aminotransferase (ALT) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3\*ULN) is reported. ULN= 55 Units/Liter.
Timepoint [7] 0 0
108 Weeks
Secondary outcome [8] 0 0
Percentage of Participants With AST Elevations > 3*ULN
Assessment method [8] 0 0
Blood was collected for the Liver Function Test: Aspartate aminotransferase (AST) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3\*ULN) is reported. ULN= 40 Units/Liter.
Timepoint [8] 0 0
108 Weeks
Secondary outcome [9] 0 0
Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study
Assessment method [9] 0 0
Blood samples were collected for liver function test: Alanine aminotransferase (serum glutamic-pyruvic transaminase) \[ALT(SGPT)\] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for ALT=55 Units/Liter. The number of participants categorized by the highest value for ALT/GPT during the study is reported: Normal (ALT result within the central lab reference range), Greater than the ULN to 1.5 times the ULN (\>ULN to 1.5\*ULN), 1.5 times the ULN to 3 times the ULN (1.5\*ULN to 3\*ULN) and 3 times the ULN to 5 times the ULN (3\*ULN to 5\*ULN).
Timepoint [9] 0 0
108 Weeks
Secondary outcome [10] 0 0
Number of Participants Categorized by Worst Value for AST (SGOT) During the Study
Assessment method [10] 0 0
Blood samples were collected for liver function test: Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) \[AST (SGOT)\] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for AST=40 Units/Liter. The number of participants categorized by worst value for AST(SGOT) during the study is reported: Normal (AST result is within the central lab reference range), Greater than the ULN to 1.5 times the ULN (\>ULN to 1.5\*ULN), 1.5 times the ULN to 3 times the ULN (1.5\*ULN to 3\*ULN) and 3 times the ULN to 5 times the ULN (3\*ULN to 5\*ULN).
Timepoint [10] 0 0
108 Weeks
Secondary outcome [11] 0 0
Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study
Assessment method [11] 0 0
Blood samples were collected for LDL Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for LDL Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.
Timepoint [11] 0 0
108 Weeks
Secondary outcome [12] 0 0
Number of Participants Categorized by Worst Value for Total Cholesterol During the Study
Assessment method [12] 0 0
Blood samples were collected for Total Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by worst value for Total Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.
Timepoint [12] 0 0
108 Weeks
Secondary outcome [13] 0 0
Number of Participants Categorized by Worst Value for Neutrophil Count During the Study
Assessment method [13] 0 0
Blood samples were collected for a Neutrophil Count every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for Neutrophil Count during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.
Timepoint [13] 0 0
108 Weeks
Secondary outcome [14] 0 0
Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)
Assessment method [14] 0 0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Clinical meaningful improvement was defined as a = 1.2 unit reduction in DAS28.
Timepoint [14] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [15] 0 0
Percentage of Participants With DAS28 Low Disease Activity
Assessment method [15] 0 0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Low Disease Activity was defined as a score of \< 3.2.
Timepoint [15] 0 0
Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [16] 0 0
Percentage of Participants With DAS28 Remission
Assessment method [16] 0 0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission was defined as a DAS28 score \< 2.6.
Timepoint [16] 0 0
Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [17] 0 0
Change From Baseline in DAS28
Assessment method [17] 0 0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
Timepoint [17] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [18] 0 0
Change From Baseline in Tender Joint Count
Assessment method [18] 0 0
68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.
Timepoint [18] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [19] 0 0
Change From Baseline in Swollen Joint Count
Assessment method [19] 0 0
66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.
Timepoint [19] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [20] 0 0
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)
Assessment method [20] 0 0
The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.
Timepoint [20] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [21] 0 0
Change From Baseline in Patient Global Assessment of Disease Activity VAS
Assessment method [21] 0 0
The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Timepoint [21] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [22] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity VAS
Assessment method [22] 0 0
The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Timepoint [22] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [23] 0 0
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Assessment method [23] 0 0
Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.
Timepoint [23] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [24] 0 0
Change From Baseline in C-Reactive Protein (CRP)
Assessment method [24] 0 0
Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.
Timepoint [24] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [25] 0 0
Percentage of Participants With American College of Rheumatology 20 (ACR20) Response
Assessment method [25] 0 0
ACR20 response was defined as a = 20 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Timepoint [25] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [26] 0 0
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
Assessment method [26] 0 0
ACR50 response is defined as a = 50 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Timepoint [26] 0 0
Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108
Secondary outcome [27] 0 0
Percentage of Participants With American College of Rheumatology 70 (ACR70) Response
Assessment method [27] 0 0
ACR70 response is defined as a = 70 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Timepoint [27] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [28] 0 0
Percentage of Participants With American College of Rheumatology 90 (ACR90) Response
Assessment method [28] 0 0
ACR90 response is defined as a = 90 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Timepoint [28] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [29] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response
Assessment method [29] 0 0
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Timepoint [29] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [30] 0 0
Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response
Assessment method [30] 0 0
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinically meaningful improvement is defined as a reduction from Baseline in the HAQ-DI score = 0.2.
Timepoint [30] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [31] 0 0
Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission
Assessment method [31] 0 0
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinical Remission is defined as a HAQ-DI score \< 0.5.
Timepoint [31] 0 0
Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [32] 0 0
Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score
Assessment method [32] 0 0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.
Timepoint [32] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [33] 0 0
Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score
Assessment method [33] 0 0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.
Timepoint [33] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108
Secondary outcome [34] 0 0
Change From Baseline in FACIT-Fatigue Score
Assessment method [34] 0 0
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's 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 patient'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 reflects an improvement in the patient's health status. A positive change from Baseline indicated improvement.
Timepoint [34] 0 0
Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108

Eligibility
Key inclusion criteria
- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-as for MA21573.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
934
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Cairns
Recruitment hospital [5] 0 0
- Adelaide
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
5041 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Canada
State/province [7] 0 0
Saskatchewan
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Bruntal
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Ostrava
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Sokolov
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Uherske Hradiste
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Zlin
Country [14] 0 0
France
State/province [14] 0 0
Belfort
Country [15] 0 0
France
State/province [15] 0 0
Caen
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Heraklion
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Budapest
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Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00883753