A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01186744
First received: August 20, 2010
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: January 27, 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
Intervention: 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
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 BID (Period A) Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
CP-690,550 10 mg BID (Period A) Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 5 mg/Placebo/CP-690,550 5 mg Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 10 mg / Placebo / CP-690,550 10 mg Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)

Participant Flow:   Overall Study
    CP-690,550 5 mg BID (Period A)     CP-690,550 10 mg BID (Period A)     CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg     CP-690,550 5 mg/Placebo/CP-690,550 5 mg     CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg     CP-690,550 10 mg / Placebo / CP-690,550 10 mg  
STARTED     218     157     31     82     45     133  
COMPLETED     10     5     25     70     39     107  
NOT COMPLETED     208     152     6     12     6     26  
Lack of Efficacy                 156                 99                 0                 2                 2                 5  
Protocol Violation                 1                 2                 0                 1                 1                 2  
Lost to Follow-up                 15                 16                 2                 1                 1                 4  
Screen failure                 1                 1                 0                 1                 0                 0  
Withdrawal by Subject                 14                 10                 2                 5                 0                 6  
Study terminated by Sponsor                 1                 0                 0                 0                 0                 0  
Not specified                 9                 10                 1                 2                 1                 5  
Adverse Event                 10                 14                 1                 0                 1                 4  
Death                 1                 0                 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.
Full Analysis Set (FAS) included all participants who were randomized at baseline and received at least one dose of the randomized investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period A.

Reporting Groups
  Description
CP-690,550 5 mg BID (Period A) Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
CP-690,550 10 mg BID (Period A) Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 5 mg/Placebo/CP-690,550 5 mg Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
CP-690,550 10 mg / Placebo / CP-690,550 10 mg Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
Total Total of all reporting groups

Baseline Measures
    CP-690,550 5 mg BID (Period A)     CP-690,550 10 mg BID (Period A)     CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg     CP-690,550 5 mg/Placebo/CP-690,550 5 mg     CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg     CP-690,550 10 mg / Placebo / CP-690,550 10 mg     Total  
Number of Participants  
[units: participants]
  218     157     31     82     45     133     666  
Age  
[units: years]
Mean ± Standard Deviation
  42.8  ± 13.0     45.6  ± 12.6     44.3  ± 13.0     45.2  ± 13.4     48.5  ± 14.8     46.1  ± 13.4     44.9  ± 13.2  
Gender  
[units: participants]
             
Female     65     50     11     27     11     44     208  
Male     153     107     20     55     34     89     458  



  Outcome Measures
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1.  Primary:   Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)   [ Time Frame: Weeks 4, 8 12, and 16 (Period B) ]

2.  Primary:   Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

3.  Primary:   Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

4.  Primary:   Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

5.  Secondary:   Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

6.  Secondary:   Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

7.  Secondary:   Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

8.  Secondary:   Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

9.  Secondary:   Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

10.  Secondary:   Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)   [ Time Frame: Weeks 4 and 8 (Period B) ]

11.  Secondary:   Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

12.  Secondary:   Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) ]

13.  Secondary:   Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) ]

14.  Secondary:   Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

15.  Secondary:   Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

16.  Secondary:   Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

17.  Secondary:   Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

18.  Secondary:   Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

19.  Secondary:   Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

20.  Secondary:   Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

21.  Secondary:   Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

22.  Secondary:   Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

23.  Secondary:   Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

24.  Secondary:   Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

25.  Secondary:   Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

26.  Secondary:   Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

27.  Secondary:   Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

28.  Secondary:   Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

29.  Secondary:   Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

30.  Secondary:   Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

31.  Secondary:   Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

32.  Secondary:   Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

33.  Secondary:   Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

34.  Secondary:   Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

35.  Secondary:   Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

36.  Secondary:   Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

37.  Secondary:   Mean PASI Score During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

38.  Secondary:   Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

39.  Secondary:   Mean PASI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

40.  Secondary:   Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

41.  Secondary:   Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

42.  Secondary:   Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

43.  Secondary:   Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

44.  Secondary:   Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

45.  Secondary:   Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

46.  Secondary:   Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

47.  Secondary:   Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

48.  Secondary:   Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

49.  Secondary:   Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

50.  Secondary:   Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

51.  Secondary:   Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

52.  Secondary:   Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

53.  Secondary:   Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

54.  Secondary:   Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

55.  Secondary:   Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

56.  Secondary:   Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

57.  Secondary:   Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

58.  Secondary:   Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

59.  Secondary:   Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

60.  Secondary:   Mean ISI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

61.  Secondary:   Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

62.  Secondary:   Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

63.  Secondary:   Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

64.  Secondary:   Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

65.  Secondary:   Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

66.  Secondary:   Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

67.  Secondary:   Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

68.  Secondary:   Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

69.  Secondary:   Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

70.  Secondary:   ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

71.  Secondary:   Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

72.  Secondary:   ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

73.  Secondary:   Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

74.  Secondary:   ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

75.  Secondary:   Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

76.  Secondary:   ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

77.  Secondary:   Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

78.  Secondary:   Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

79.  Secondary:   Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

80.  Secondary:   Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

81.  Secondary:   Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

82.  Secondary:   Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

83.  Secondary:   Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

84.  Secondary:   Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

85.  Secondary:   Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

86.  Secondary:   Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

87.  Secondary:   Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

88.  Secondary:   Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

89.  Secondary:   Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

90.  Secondary:   Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

91.  Secondary:   Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

92.  Secondary:   Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

93.  Secondary:   Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

94.  Secondary:   Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

95.  Secondary:   Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

96.  Secondary:   Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ]

97.  Secondary:   Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

98.  Secondary:   Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

99.  Secondary:   Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

100.  Secondary:   Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]

101.  Secondary:   Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Week 24 (Period A) ]

102.  Secondary:   Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Week 56 (Period C) ]

103.  Secondary:   Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Week 24 (Period A) ]

104.  Secondary:   Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Week 56 (Period C) ]

105.  Secondary:   Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Week 24 (Period A) ]

106.  Secondary:   Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Week 56 (Period C) ]

107.  Secondary:   Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Week 24 (Period A) ]

108.  Secondary:   Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Week 56 (Period C) ]

109.  Secondary:   Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Baseline and Weeks 4, 8, 16 and 24 (Period A) ]

110.  Secondary:   Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ]

111.  Secondary:   Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

112.  Secondary:   Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

113.  Secondary:   Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)   [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ]

114.  Secondary:   Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

115.  Secondary:   Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

116.  Secondary:   Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Week 56 (Period C) ]

117.  Secondary:   Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)   [ Time Frame: Week 24 (Period A) ]

118.  Secondary:   Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Week 56 (Period C) ]

119.  Secondary:   Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)   [ Time Frame: Baseline and Week 24 (Period A) ]

120.  Secondary:   Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Baseline and Week 56 (Period C) ]

121.  Secondary:   Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)   [ Time Frame: Week 24 (Period A) ]

122.  Secondary:   Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Week 56 (Period C) ]

123.  Secondary:   Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)   [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ]

124.  Secondary:   Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)   [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ]

125.  Secondary:   Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)   [ Time Frame: Weeks 4, 8, and 16 (Period C) ]


  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
Clinical interpretation regarding sub-phenotypes of psoriasis (e.g., scalp psoriasis) should not be made based on the reported assessments by body regions. For example, the body region of head does not reflect solely scalp psoriasis.


  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: NCT01186744     History of Changes
Other Study ID Numbers: A3921111
Study First Received: August 20, 2010
Results First Received: January 27, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration