Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00413660
First received: December 18, 2006
Last updated: January 14, 2013
Last verified: January 2013
Results First Received: December 4, 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
Other: 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 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 24 weeks.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 1 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 20 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.

Participant Flow for 2 periods

Period 1:   Up To Week 12
    CP-690,550 1 mg     CP-690,550 3 mg     CP-690,550 5 mg     CP-690,550 10 mg     CP-690,550 15 mg     CP-690,550 20 mg     Placebo     CP-690,550 1 mg to CP-690,550 5 mg (R)     CP-690,550 3 mg to CP-690,550 5 mg (R)     CP-690,550 20 mg to CP-690,550 5 mg (R)     Placebo to CP-690,550 5 mg (R)  
STARTED     71     68     71     75     75     80     69     0     0     0     0  
Treated     70     68     71     74     75     80     69     0     0     0     0  
COMPLETED     64     61     64     67     66     70     58     0     0     0     0  
NOT COMPLETED     7     7     7     8     9     10     11     0     0     0     0  
Adverse Event                 1                 3                 1                 4                 6                 4                 1                 0                 0                 0                 0  
Lack of Efficacy                 2                 0                 0                 0                 0                 0                 5                 0                 0                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 2                 0                 2                 0                 2                 2                 0                 0                 0                 0  
Randomized, Not Treated                 1                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0  
Unspecified                 3                 1                 6                 1                 2                 4                 3                 0                 0                 0                 0  

Period 2:   Post Week 12
    CP-690,550 1 mg     CP-690,550 3 mg     CP-690,550 5 mg     CP-690,550 10 mg     CP-690,550 15 mg     CP-690,550 20 mg     Placebo     CP-690,550 1 mg to CP-690,550 5 mg (R)     CP-690,550 3 mg to CP-690,550 5 mg (R)     CP-690,550 20 mg to CP-690,550 5 mg (R)     Placebo to CP-690,550 5 mg (R)  
STARTED     43     48     64     67     66     57     40     21     13     13     18  
COMPLETED     40     44     56     66     60     54     37     21     13     12     17  
NOT COMPLETED     3     4     8     1     6     3     3     0     0     1     1  
Adverse Event                 2                 0                 2                 1                 4                 2                 2                 0                 0                 0                 0  
Lack of Efficacy                 0                 0                 1                 0                 0                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 1                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 1                 1                 0                 1                 0                 0                 0                 0                 0                 1  
Unspecified                 1                 2                 3                 0                 1                 1                 1                 0                 0                 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.
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Reporting Groups
  Description
CP-690,550 1 mg CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 24 weeks.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Total Total of all reporting groups

Baseline Measures
    CP-690,550 1 mg     CP-690,550 3 mg     CP-690,550 5 mg     CP-690,550 10 mg     CP-690,550 15 mg     CP-690,550 20 mg     Placebo     Total  
Number of Participants  
[units: participants]
  70     68     71     74     75     80     69     507  
Age, Customized  
[units: participants]
               
18 to 44 Years     15     23     19     9     14     15     17     112  
45 to 64 Years     47     31     42     49     49     49     40     307  
Greater Than or Equal to (>=) 65 Years     8     14     10     16     12     16     12     88  
Gender  
[units: participants]
               
Female     57     52     57     55     66     63     56     406  
Male     13     16     14     19     9     17     13     101  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET) ]

3.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

5.  Secondary:   Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve   [ Time Frame: Baseline up to Week 2, 4, 6, 8, 12 ]

6.  Secondary:   Tender Joints Count (TJC)   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

7.  Secondary:   Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

8.  Secondary:   Swollen Joints Count (SJC)   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

9.  Secondary:   Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

10.  Secondary:   Patient Assessment of Arthritis Pain   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

11.  Secondary:   Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

12.  Secondary:   Patient Global Assessment (PtGA) of Arthritis   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

13.  Secondary:   Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

14.  Secondary:   Physician Global Assessment of Arthritis   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

15.  Secondary:   Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

16.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI)   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

17.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

18.  Secondary:   C-Reactive Protein (CRP)   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

19.  Secondary:   Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

20.  Secondary:   Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

21.  Secondary:   Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET   [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

22.  Secondary:   Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)   [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

23.  Secondary:   Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)   [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

24.  Secondary:   36-Item Short-Form Health Survey (SF-36)   [ Time Frame: Baseline, Week 12, 24/ET ]

25.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET   [ Time Frame: Baseline, Week 12, 24/ET ]

26.  Secondary:   Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score   [ Time Frame: Baseline, Week 12, 24/ET ]

27.  Secondary:   Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET   [ Time Frame: Baseline, Week 12, 24/ET ]

28.  Secondary:   Medical Outcome Study- Sleep Scale (MOS-SS)   [ Time Frame: Baseline, Week 2, 12, 24/ET ]

29.  Secondary:   Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET   [ Time Frame: Baseline, Week 2, 12, 24/ET ]

30.  Secondary:   Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale   [ Time Frame: Baseline, Week 2, 12, 24/ET ]

31.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET   [ Time Frame: Baseline, Week 2, 12, 24/ET ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00413660     History of Changes
Other Study ID Numbers: A3921025
Study First Received: December 18, 2006
Results First Received: December 4, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration