A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01519089
First received: December 22, 2011
Last updated: August 6, 2015
Last verified: August 2015
Results First Received: January 8, 2015  
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: Psoriasis
Interventions: Drug: CP-690,550
Drug: CP-690, 550

  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 BID CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg BID CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.

Participant Flow:   Overall Study
    CP-690,550 5 mg BID     CP-690,550 10 mg BID  
STARTED     47     48  
Received Treatment     47     47  
COMPLETED     40     33  
NOT COMPLETED     7     15  
Adverse Event                 4                 4  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 0                 2  
Unspecified                 2                 6  
Not received study drug                 0                 1  



  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 5 mg BID CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg BID CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
Total Total of all reporting groups

Baseline Measures
    CP-690,550 5 mg BID     CP-690,550 10 mg BID     Total  
Number of Participants  
[units: participants]
  47     47     94  
Age  
[units: years]
Mean (Standard Deviation)
  50.9  (11.8)     46.4  (10.8)     48.7  (11.5)  
Gender  
[units: Participants]
     
Female     8     8     16  
Male     39     39     78  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16   [ Time Frame: Week 16 ]

2.  Primary:   Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16   [ Time Frame: Week 16 ]

3.  Primary:   Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16   [ Time Frame: Week 16 ]

4.  Primary:   Number of Participants With Adjudicated Cardiovacular Events   [ Time Frame: Baseline to Follow-up ]

5.  Primary:   Number of Participants With Malignancy Events _Week 0 Through Follow-up   [ Time Frame: Baseline to Follow-up ]

6.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response   [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ]

7.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

8.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

9.  Secondary:   Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'   [ Time Frame: Week 16 ]

10.  Secondary:   Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response   [ Time Frame: Week 16 ]

11.  Secondary:   Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response   [ Time Frame: Week 16 ]

12.  Secondary:   Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response   [ Time Frame: Week 16 ]

13.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

14.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) Score   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

15.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

16.  Secondary:   Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'   [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ]

17.  Secondary:   Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

18.  Secondary:   Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16   [ Time Frame: Week 20, 28, 40, 52 ]

19.  Secondary:   Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'   [ Time Frame: Week 20, 28, 40, 52 ]

20.  Secondary:   Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score   [ Time Frame: Week 8, 16, 20, 28, 40, 52 ]

21.  Secondary:   Number of Affected Nails   [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ]

22.  Secondary:   Itch Severity Item (ISI) Score   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

23.  Secondary:   Dermatology Life Quality Index (DLQI) Score   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

24.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score   [ Time Frame: Week (W) 16, 28, 52 ]

25.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score   [ Time Frame: Week 16, 28, 52 ]

26.  Secondary:   Work Limitation Questionnaire (WLQ)   [ Time Frame: Baseline (BL), Week (W) 4, 16, 28, 52 ]

27.  Secondary:   Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

28.  Secondary:   Joint Pain Assessment (JPA)   [ Time Frame: Baseline, Week 4, 16, 28, 52 ]

29.  Secondary:   Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ]

30.  Secondary:   Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

31.  Secondary:   Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

32.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

33.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

34.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

35.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

36.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

37.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

38.  Secondary:   Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]


  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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01519089     History of Changes
Other Study ID Numbers: A3921137
Study First Received: December 22, 2011
Results First Received: January 8, 2015
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration