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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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 ]

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 ]
  Hide Outcome Measure 26

Measure Type Secondary
Measure Title Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Measure Description Participant-rated 12 item questionnaire 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 scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame Month 6  
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 population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.

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.

Measured Values
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo, Then CP-690,550 5 mg     Placebo, Then CP-690,550 10 mg  
Number of Participants Analyzed  
[units: participants]
  229     214     54     50  
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6  
[units: units on a scale]
Mean ± Standard Deviation
       
Overall sleep problem     35.68  ± 18.80     33.33  ± 19.19     37.29  ± 19.26     35.64  ± 21.20  
Sleep problem summary     35.17  ± 18.81     33.33  ± 19.66     37.41  ± 20.30     35.87  ± 20.80  
Somnolence     30.26  ± 21.01     29.42  ± 20.64     31.36  ± 19.75     29.60  ± 21.56  
Snoring     35.28  ± 31.04     27.79  ± 28.24     26.30  ± 28.50     29.20  ± 27.47  
Quantity     6.64  ± 1.45     6.87  ± 1.71     6.65  ± 1.52     6.64  ± 1.27  
Sleep disturbance     35.75  ± 25.11     33.38  ± 23.91     37.80  ± 23.96     33.80  ± 25.83  
Awaken short of breath     15.55  ± 21.67     15.70  ± 21.41     21.11  ± 21.43     23.20  ± 25.67  
Adequacy(n=229,214,54,50)     48.52  ± 27.41     53.04  ± 29.14     49.44  ± 29.36     49.00  ± 27.94  

No statistical analysis provided for Medical Outcome Study Sleep Scale (MOS-SS) at 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
  Hide Limitations and Caveats

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
No text entered.


  More Information