A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01309737
First received: March 4, 2011
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: July 24, 2014  
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: Placebo/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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outcome measures reporting results up to Week 16 consist of single placebo arm as reporting group while outcome measures reporting results up to Week 52 consist of 2 separate arms (for participants re-randomized at Week 16 to receive CP-690,550 5 milligram [mg] or 10 mg).

Reporting Groups
  Description
CP-690,550 5mg CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 52.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
Placebo, CP-690,550 5 mg Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
Placebo,CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.

Participant Flow for 2 periods

Period 1:   Week 0 to 16
    CP-690,550 5mg     CP-690,550 10 mg     Placebo     Placebo, CP-690,550 5 mg     Placebo,CP-690,550 10 mg  
STARTED     383     381     196     0     0  
Treated     382     381     196     0     0  
COMPLETED     331     341     152     0     0  
NOT COMPLETED     52     40     44     0     0  
Death                 1                 0                 1                 0                 0  
Adverse Event                 11                 10                 5                 0                 0  
Lack of Efficacy                 15                 2                 24                 0                 0  
Lost to Follow-up                 7                 8                 3                 0                 0  
Withdrawal by Subject                 7                 6                 7                 0                 0  
Unspecified                 10                 14                 4                 0                 0  
Randomized, but not treated                 1                 0                 0                 0                 0  

Period 2:   Week 16 to 52
    CP-690,550 5mg     CP-690,550 10 mg     Placebo     Placebo, CP-690,550 5 mg     Placebo,CP-690,550 10 mg  
STARTED     331     341     0     75     77  
COMPLETED     198     238     0     41     44  
NOT COMPLETED     133     103     0     34     33  
Death                 0                 0                 0                 0                 1  
Adverse Event                 7                 7                 0                 6                 5  
Lack of Efficacy                 107                 76                 0                 25                 21  
Lost to Follow-up                 4                 2                 0                 1                 4  
Withdrawal by Subject                 5                 6                 0                 0                 2  
Unspecified                 10                 12                 0                 2                 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.
Safety analysis set consisted of all participants who received at least 1 dose of the investigational drug (CP-690,550 or placebo).

Reporting Groups
  Description
CP-690,550 5mg CP-690,550 5 mg tablet orally twice daily up to Week 52.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 52.
Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
Total Total of all reporting groups

Baseline Measures
    CP-690,550 5mg     CP-690,550 10 mg     Placebo     Total  
Number of Participants  
[units: participants]
  382     381     196     959  
Age  
[units: years]
Mean ± Standard Deviation
  45.9  ± 12.9     44.3  ± 13.0     44.8  ± 12.6     45.0  ± 12.9  
Gender  
[units: participants]
       
Female     114     124     73     311  
Male     268     257     123     648  



  Outcome Measures

1.  Primary:   Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16   [ Time Frame: Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

2.  Primary:   Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16   [ Time Frame: Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16   [ Time Frame: Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Dermatology Life Quality Index (DLQI) Total Score   [ Time Frame: Baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16   [ Time Frame: Baseline, Week 4,16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4   [ Time Frame: Week 4 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4   [ Time Frame: Week 4 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’   [ Time Frame: Baseline up to Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response   [ Time Frame: Baseline up to Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response   [ Time Frame: Baseline up to Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response   [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   Psoriasis Area and Severity Index (PASI) Score   [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

20.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

21.  Secondary:   Psoriasis Area and Severity Index (PASI) Component Scores   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

22.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

23.  Secondary:   Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

24.  Secondary:   Total Body Surface Area (BSA) With Psoriasis   [ Time Frame: Baseline, Week 2, 4, 8,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

25.  Secondary:   Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

26.  Secondary:   Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response   [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

27.  Secondary:   Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response   [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

28.  Secondary:   Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score   [ Time Frame: Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

29.  Secondary:   Nail Psoriasis Severity Index (NAPSI) Score   [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

30.  Secondary:   Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52   [ Time Frame: Baseline,Week 8, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

31.  Secondary:   Number of Affected Nails   [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

32.  Secondary:   Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52   [ Time Frame: Baseline,Week 8,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

33.  Secondary:   Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response   [ Time Frame: Week 8, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

34.  Secondary:   Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response   [ Time Frame: Week 8,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

35.  Secondary:   Itch Severity Item (ISI) Score   [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

36.  Secondary:   Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

37.  Secondary:   Dermatology Life Quality Index (DLQI) Score   [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

38.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

39.  Secondary:   36-Item Short-Form Health Survey Version 2, Acute (SF-36)   [ Time Frame: Baseline, Week 16, 28, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

40.  Secondary:   Hospital Anxiety and Depression Scale (HADS) Score   [ Time Frame: Baseline, Week 8, 16, 28, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

41.  Secondary:   Work Limitation Questionnaire (WLQ) Index Score   [ Time Frame: Baseline, Week 8, 16, 28, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

42.  Secondary:   Percentage of Participants With Patient Global Assessment (PtGA) Scale Response   [ Time Frame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

43.  Secondary:   Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response   [ Time Frame: Week 16, 28, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

44.  Secondary:   Joint Pain Assessment (JPA) Score   [ Time Frame: Baseline, Week 8,16, 28, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

45.  Secondary:   Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score   [ Time Frame: Baseline, Week 16, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

46.  Secondary:   Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)   [ Time Frame: Baseline,Week 16, 28, 40, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

47.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

48.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

49.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status   [ Time Frame: Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

50.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

51.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

52.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work   [ Time Frame: Baseline, Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

53.  Secondary:   Family Dermatology Life Quality Index (FDLQI) Score   [ Time Frame: Baseline, Week 16, 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: NCT01309737     History of Changes
Other Study ID Numbers: A3921079
Study First Received: March 4, 2011
Results First Received: July 24, 2014
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration