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A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00814307
First received: December 22, 2008
Last updated: January 10, 2013
Last verified: January 2013
Results First Received: December 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: CP-690,550
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

Participant Flow:   Overall Study
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg  
STARTED     244     245     61     61  
Treated     243     245     61     61  
COMPLETED     232     218     54     51  
NOT COMPLETED     12     27     7     10  
Randomized but not treated                 1                 0                 0                 0  
Adverse Event                 3                 9                 3                 2  
Lack of Efficacy                 1                 1                 3                 4  
Unspecified                 1                 2                 0                 1  
Protocol Violation                 2                 8                 1                 1  
Withdrawal by Subject                 4                 6                 0                 2  
Death                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Total Total of all reporting groups

Baseline Measures
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg     Total  
Number of Participants  
[units: participants]
  243     245     61     61     610  
Age  
[units: Years]
Mean ± Standard Deviation
  52.2  ± 11.5     52.4  ± 11.7     50.7  ± 12.8     48.8  ± 11.9     51.8  ± 11.8  
Gender  
[units: Participants]
         
Female     207     216     54     51     528  
Male     36     29     7     10     82  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3   [ Time Frame: Month 3 ]

2.  Primary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3   [ Time Frame: Baseline, Month 3 ]

3.  Primary:   Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3   [ Time Frame: Month 3 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2   [ Time Frame: Week 2, Month 1, 2 ]

5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3   [ Time Frame: Week 2, Month 1, 2, 3 ]

7.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3   [ Time Frame: Week 2, Month 1, 2, 3 ]

9.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

10.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

11.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6   [ Time Frame: Month 6 ]

12.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

13.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

14.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

15.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

16.  Secondary:   Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
  Hide Outcome Measure 16

Measure Type Secondary
Measure Title Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Measure Description Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time Frame Baseline, Week 2, Month 1, 2, 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo Matching placebo tablet orally twice daily up to Month 3.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  241     243     122  
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3  
[units: mm]
Mean ± Standard Deviation
     
Baseline (n= 241, 243, 122)     61.35  ± 22.27     62.03  ± 23.63     61.79  ± 21.27  
Week 2 (n= 239, 239, 119)     45.92  ± 22.87     42.13  ± 25.06     55.61  ± 23.63  
Month 1 (n= 237, 240, 116)     40.68  ± 23.04     36.86  ± 24.46     52.47  ± 24.59  
Month 2 (n= 240, 233, 110)     36.39  ± 23.29     31.66  ± 24.38     52.38  ± 26.09  
Month 3 (n= 237, 228, 108)     34.93  ± 23.73     31.37  ± 24.35     49.84  ± 25.10  

No statistical analysis provided for Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3



17.  Secondary:   Patient Assessment of Arthritis Pain at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

18.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

19.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

20.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3   [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

21.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6   [ Time Frame: Month 4, 5, 6 ]

22.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3   [ Time Frame: Baseline, Month 3 ]

23.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Month 6   [ Time Frame: Month 6 ]

24.  Secondary:   Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

25.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

26.  Secondary:   Medical Outcome Study Sleep Scale (MOS-SS) at Month 6   [ Time Frame: Month 6 ]

27.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6   [ Time Frame: Month 6 ]

28.  Secondary:   Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

29.  Secondary:   Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6   [ Time Frame: Month 6 ]

30.  Secondary:   Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

31.  Secondary:   Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6   [ Time Frame: Month 6 ]

32.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

33.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6   [ Time Frame: Month 6 ]

34.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

35.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

36.  Secondary:   Number of Days as Assessed Using RA-HCRU at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

37.  Secondary:   Number of Days as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

38.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

39.  Secondary:   Number of Hours Per Days as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

40.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

41.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6   [ Time Frame: Month 6 ]

42.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3   [ Time Frame: Baseline, Month 3 ]

43.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Month 6   [ Time Frame: Month 6 ]

44.  Other Pre-specified:   Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain   [ Time Frame: 2 weeks ]

45.  Other Pre-specified:   Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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