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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00960440




Registration number
NCT00960440
Ethics application status
Date submitted
14/08/2009
Date registered
17/08/2009
Date last updated
19/12/2018

Titles & IDs
Public title
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
Scientific title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
Secondary ID [1] 0 0
A3921032
Universal Trial Number (UTN)
Trial acronym
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 - Placebo
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550

Experimental: Sequence 1 -

Experimental: Sequence 2 -

Placebo comparator: Sequence 3 -

Placebo comparator: Sequence 4 -


Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
Timepoint [1] 0 0
Month 3
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Timepoint [2] 0 0
Baseline, Month 3
Primary outcome [3] 0 0
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Timepoint [3] 0 0
Month 3
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
Timepoint [1] 0 0
Week 2, Month 1
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
Timepoint [2] 0 0
Month 4.5, 6
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
Timepoint [3] 0 0
Week 2, Month 1, 3
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
Timepoint [4] 0 0
Month 4.5 and 6
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
Timepoint [5] 0 0
Week 2, Month 1, 3
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
Timepoint [6] 0 0
Month 4.5, 6
Secondary outcome [7] 0 0
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Timepoint [7] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [8] 0 0
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
Timepoint [8] 0 0
Month 4.5, 6
Secondary outcome [9] 0 0
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Timepoint [9] 0 0
Baseline, Month 3
Secondary outcome [10] 0 0
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
Timepoint [10] 0 0
Month 6
Secondary outcome [11] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
Timepoint [11] 0 0
Week 2, Month 1, 3
Secondary outcome [12] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
Timepoint [12] 0 0
Month 4.5, 6
Secondary outcome [13] 0 0
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Timepoint [13] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [14] 0 0
Patient Assessment of Arthritis Pain at Month 4.5 and 6
Timepoint [14] 0 0
Month 4.5, 6
Secondary outcome [15] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Timepoint [15] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [16] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
Timepoint [16] 0 0
Month 4.5, 6
Secondary outcome [17] 0 0
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
Timepoint [17] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [18] 0 0
Physician Global Assessment of Arthritis at Month 4.5 and 6
Timepoint [18] 0 0
Month 4.5, 6
Secondary outcome [19] 0 0
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Timepoint [19] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [20] 0 0
36-Item Short-Form Health Survey (SF-36) at Month 6
Timepoint [20] 0 0
Month 6
Secondary outcome [21] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Timepoint [21] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [22] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Timepoint [22] 0 0
Month 6
Secondary outcome [23] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Timepoint [23] 0 0
Baseline, Week 2, Month 1, 3
Secondary outcome [24] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Timepoint [24] 0 0
Month 6
Secondary outcome [25] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Timepoint [25] 0 0
Baseline, Month 3
Secondary outcome [26] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
Timepoint [26] 0 0
Month 6
Secondary outcome [27] 0 0
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
Timepoint [27] 0 0
Baseline, Month 1, 3
Secondary outcome [28] 0 0
Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6
Timepoint [28] 0 0
Month 6
Secondary outcome [29] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Timepoint [29] 0 0
Baseline, Month 3
Secondary outcome [30] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Timepoint [30] 0 0
Month 6
Secondary outcome [31] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Timepoint [31] 0 0
Baseline, Month 3
Secondary outcome [32] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Timepoint [32] 0 0
Month 6
Secondary outcome [33] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Timepoint [33] 0 0
Baseline, Month 3
Secondary outcome [34] 0 0
Number of Days as Assessed Using RA-HCRU at Month 6
Timepoint [34] 0 0
Month 6
Secondary outcome [35] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Timepoint [35] 0 0
Baseline, Month 3
Secondary outcome [36] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Timepoint [36] 0 0
Month 6
Secondary outcome [37] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Timepoint [37] 0 0
Baseline, Month 3
Secondary outcome [38] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
Timepoint [38] 0 0
Month 6
Secondary outcome [39] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Timepoint [39] 0 0
Baseline, Month 3
Secondary outcome [40] 0 0
Work Limitations Questionnaire (WLQ) Score at Month 6
Timepoint [40] 0 0
Month 6

Eligibility
Key inclusion criteria
* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

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
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Kogarah
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5041 - Daw Park
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Belgium
State/province [22] 0 0
Genk
Country [23] 0 0
Belgium
State/province [23] 0 0
Hasselt
Country [24] 0 0
Belgium
State/province [24] 0 0
Kortrijk
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Brazil
State/province [26] 0 0
GO
Country [27] 0 0
Brazil
State/province [27] 0 0
PR
Country [28] 0 0
Brazil
State/province [28] 0 0
RS
Country [29] 0 0
Brazil
State/province [29] 0 0
SP
Country [30] 0 0
Canada
State/province [30] 0 0
Manitoba
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
France
State/province [33] 0 0
Amiens
Country [34] 0 0
France
State/province [34] 0 0
Lyon
Country [35] 0 0
France
State/province [35] 0 0
Orleans Cedex 1
Country [36] 0 0
France
State/province [36] 0 0
Orleans
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Erlangen
Country [40] 0 0
Germany
State/province [40] 0 0
Frankfurt am Main
Country [41] 0 0
Germany
State/province [41] 0 0
Halle
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Koeln
Country [44] 0 0
Germany
State/province [44] 0 0
Leipzig
Country [45] 0 0
Germany
State/province [45] 0 0
Rheine
Country [46] 0 0
Germany
State/province [46] 0 0
Wuerzburg
Country [47] 0 0
Ireland
State/province [47] 0 0
Co. Limerick
Country [48] 0 0
Ireland
State/province [48] 0 0
Dublin
Country [49] 0 0
Italy
State/province [49] 0 0
Firenze
Country [50] 0 0
Italy
State/province [50] 0 0
Jesi
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Busan
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Daegu
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Puerto Rico
State/province [54] 0 0
San Juan
Country [55] 0 0
Spain
State/province [55] 0 0
A Coruña
Country [56] 0 0
Spain
State/province [56] 0 0
Badajoz
Country [57] 0 0
Spain
State/province [57] 0 0
Bizkaia
Country [58] 0 0
Spain
State/province [58] 0 0
Cantabria
Country [59] 0 0
Spain
State/province [59] 0 0
Vizcaya
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Valencia
Country [62] 0 0
Taiwan
State/province [62] 0 0
Kaohsiung County
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taoyuan County
Country [64] 0 0
Taiwan
State/province [64] 0 0
Changhua
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00960440