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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01276639
First received: January 12, 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 5 mg 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 thereafter 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 5 mg     CP-690,550 10 mg     Placebo     Placebo, CP-690,550 5 mg     Placebo, CP-690,550 10 mg  
STARTED     363     361     177     0     0  
Treated     363     360     177     0     0  
COMPLETED     313     320     132     0     0  
NOT COMPLETED     50     41     45     0     0  
Death                 1                 0                 0                 0                 0  
Adverse Event                 11                 8                 11                 0                 0  
Lack of Efficacy                 20                 15                 25                 0                 0  
Lost to Follow-up                 3                 5                 3                 0                 0  
Withdrawal by Subject                 8                 5                 4                 0                 0  
Unspecified                 7                 7                 2                 0                 0  
Randomized, But Not Treated                 0                 1                 0                 0                 0  

Period 2:   Week 16 to 52
    CP-690,550 5 mg     CP-690,550 10 mg     Placebo     Placebo, CP-690,550 5 mg     Placebo, CP-690,550 10 mg  
STARTED     313     320     0     66     66  
COMPLETED     186     219     0     50     45  
NOT COMPLETED     127     101     0     16     21  
Death                 1                 0                 0                 0                 0  
Adverse Event                 10                 13                 0                 1                 3  
Lack of Efficacy                 99                 71                 0                 14                 13  
Lost to Follow-up                 3                 1                 0                 0                 1  
Withdrawal by Subject                 4                 4                 0                 0                 1  
Unspecified                 10                 12                 0                 1                 3  



  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.
Safety analysis set included all participants who received at least 1 dose of investigational drug (CP-690,550 or placebo).

Reporting Groups
  Description
CP-690,550 5 mg 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 5 mg     CP-690,550 10 mg     Placebo     Total  
Number of Participants  
[units: participants]
  363     360     177     900  
Age  
[units: years]
Mean ± Standard Deviation
  45.6  ± 13.4     45.2  ± 12.8     45.0  ± 12.6     45.3  ± 13.0  
Gender  
[units: participants]
       
Female     102     99     56     257  
Male     261     261     121     643  



  Outcome Measures
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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 ]

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

3.  Secondary:   Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16   [ Time Frame: Baseline, Week 16 ]

4.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16   [ Time Frame: Week 16 ]

5.  Secondary:   Dermatology Life Quality Index (DLQI) Total Score   [ Time Frame: Baseline ]

6.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16   [ Time Frame: Week 4, 16 ]

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 ]

8.  Secondary:   Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4   [ Time Frame: Week 4 ]

9.  Secondary:   Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16   [ Time Frame: Baseline, Week 16 ]

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 ]

11.  Secondary:   Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52   [ Time Frame: Week 52 ]

12.  Secondary:   Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52   [ Time Frame: Week 52 ]

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 ]

14.  Secondary:   Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response   [ Time Frame: Baseline up to Week 16 ]

15.  Secondary:   Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response   [ Time Frame: Baseline up to Week 16 ]

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 ]

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 ]

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 ]

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

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 ]

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

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 ]

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 ]

24.  Secondary:   Total Body Surface Area (BSA) With Psoriasis   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ]

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 ]

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 ]

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 ]

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 ]

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

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 ]

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

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 ]

33.  Secondary:   Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response   [ Time Frame: Week 8, 16, 20, 28, 40, 52 ]

34.  Secondary:   Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response   [ Time Frame: Week 8, 16, 20, 28, 40, 52 ]

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

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 ]

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

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 ]

39.  Secondary:   36-Item Short-Form Health Survey Version 2, Acute (SF-36)   [ Time Frame: Baseline, Week 16, 28, 52 ]

40.  Secondary:   Hospital Anxiety and Depression Scale (HADS) Score   [ Time Frame: Baseline, Week 4, 16, 28, 52 ]

41.  Secondary:   Work Limitation Questionnaire (WLQ) Index Score   [ Time Frame: Baseline, Week 4, 16, 28, 52 ]

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 ]

43.  Secondary:   Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response   [ Time Frame: Week 16, 28, 52 ]

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

45.  Secondary:   Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score   [ Time Frame: Baseline, Week 16, 28, 40, 52 ]

46.  Secondary:   Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)   [ Time Frame: Baseline, Week 16, 28, 40, 52 ]

47.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional   [ Time Frame: Baseline, Week 16 ]

48.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work   [ Time Frame: Baseline, Week 16 ]

49.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status   [ Time Frame: Week 16 ]

50.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours   [ Time Frame: Baseline, Week 16 ]

51.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours   [ Time Frame: Baseline, Week 16 ]

52.  Secondary:   Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work   [ Time Frame: Baseline, Week 16 ]

53.  Secondary:   Family Dermatology Life Quality Index (FDLQI) Score   [ Time Frame: Baseline, Week 16, 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: NCT01276639     History of Changes
Other Study ID Numbers: A3921078
Study First Received: January 12, 2011
Results First Received: July 24, 2014
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration