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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01186744




Registration number
NCT01186744
Ethics application status
Date submitted
20/08/2010
Date registered
23/08/2010
Date last updated
26/12/2018

Titles & IDs
Public title
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
Scientific title
A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Secondary ID [1] 0 0
A3921111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550

Experimental: Active Treatment (10 mg) BID / Placebo BID - Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Experimental: Active Treatment (10 mg) BID - Continuous active treatment (CP-690,550) for 56 weeks

Experimental: Active Treatment (5 mg) BID / Placebo BID - Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Experimental: Active Treatment (5 mg) BID - Continuous active treatment (CP-690,550) for 56 weeks


Treatment: Drugs: CP-690,550
10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Treatment: Drugs: CP-690,550
10 mg oral BID

Treatment: Drugs: CP-690,550
5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Treatment: Drugs: CP-690,550
5 mg oral BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
Timepoint [1] 0 0
Weeks 4, 8 12, and 16 (Period B)
Primary outcome [2] 0 0
Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [2] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [1] 0 0
Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
Timepoint [1] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [2] 0 0
Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
Timepoint [2] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [4] 0 0
Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [4] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [5] 0 0
Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [5] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Weeks 4 and 8 (Period B)
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [8] 0 0
Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [8] 0 0
Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [15] 0 0
Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
Timepoint [15] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [16] 0 0
Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
Timepoint [16] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [17] 0 0
Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
Timepoint [17] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [18] 0 0
Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
Timepoint [18] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [19] 0 0
Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
Timepoint [19] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [20] 0 0
Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
Timepoint [20] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [21] 0 0
Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
Timepoint [21] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [22] 0 0
Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Timepoint [22] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [23] 0 0
Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Timepoint [23] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [24] 0 0
Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
Timepoint [24] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [25] 0 0
Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Timepoint [25] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [26] 0 0
Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Timepoint [26] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [27] 0 0
Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Timepoint [27] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [28] 0 0
Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Timepoint [28] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [29] 0 0
Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Timepoint [29] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [30] 0 0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Timepoint [30] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [31] 0 0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Timepoint [31] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [32] 0 0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Timepoint [32] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [33] 0 0
Mean PASI Score During Initial CP-690,550 Treatment (Period A)
Timepoint [33] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [34] 0 0
Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
Timepoint [34] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [35] 0 0
Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [35] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [36] 0 0
Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
Timepoint [36] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [37] 0 0
Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
Timepoint [37] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [38] 0 0
Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [38] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [39] 0 0
Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Timepoint [39] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [40] 0 0
Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Timepoint [40] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [41] 0 0
Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Timepoint [41] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [42] 0 0
Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Timepoint [42] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [43] 0 0
Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Timepoint [43] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [44] 0 0
Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Timepoint [44] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [45] 0 0
Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A
Timepoint [45] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [46] 0 0
Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A
Timepoint [46] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [47] 0 0
Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A
Timepoint [47] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [48] 0 0
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)
Timepoint [48] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [49] 0 0
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)
Timepoint [49] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [50] 0 0
Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)
Timepoint [50] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [51] 0 0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)
Timepoint [51] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [52] 0 0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)
Timepoint [52] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [53] 0 0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [53] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [54] 0 0
Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)
Timepoint [54] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [55] 0 0
Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [55] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [56] 0 0
Mean ISI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [56] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [57] 0 0
Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)
Timepoint [57] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [58] 0 0
Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [58] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [59] 0 0
Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [59] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [60] 0 0
Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)
Timepoint [60] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [61] 0 0
Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)
Timepoint [61] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [62] 0 0
Percentage of Participants Achieving ISI Score of =1 During the Initial CP-690,550 Treatment (Period A)
Timepoint [62] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [63] 0 0
Percentage of Participants Achieving an ISI Score of =1 During CP-690,550 Re-Treatment (Period C)
Timepoint [63] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [64] 0 0
Percentage of Participants Achieving ISI =2-Point Reduction During the Initial CP-690,550 Treatment (Period A)
Timepoint [64] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [65] 0 0
Percentage of Participants Achieving ISI =2-Point Reduction During the CP-690,550 Re-Treatment (Period C)
Timepoint [65] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [66] 0 0
ISI Score of =1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
Timepoint [66] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [67] 0 0
Median Time to ISI Score of =1 During the Initial CP-690,550 Treatment (Period A)
Timepoint [67] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [68] 0 0
ISI Score of =1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response
Timepoint [68] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [69] 0 0
Median Time to ISI Score of =1 During the CP-690,550 Re-Treatment (Period C)
Timepoint [69] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [70] 0 0
ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
Timepoint [70] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [71] 0 0
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)
Timepoint [71] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [72] 0 0
ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response
Timepoint [72] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [73] 0 0
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)
Timepoint [73] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [74] 0 0
Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)
Timepoint [74] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [75] 0 0
Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [75] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [76] 0 0
Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [76] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [77] 0 0
Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)
Timepoint [77] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [78] 0 0
Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [78] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [79] 0 0
Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)
Timepoint [79] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [80] 0 0
Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
Timepoint [80] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [81] 0 0
Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [81] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [82] 0 0
Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
Timepoint [82] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [83] 0 0
Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
Timepoint [83] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [84] 0 0
Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
Timepoint [84] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [85] 0 0
Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
Timepoint [85] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [86] 0 0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Timepoint [86] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [87] 0 0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)
Timepoint [87] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [88] 0 0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)
Timepoint [88] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [89] 0 0
Percentage of Participants Achieving DLQI =1 Response During the Initial CP-690,550 Treatment (Period A)
Timepoint [89] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [90] 0 0
Percentage of Participants Achieving DLQI =1 Response During Double-Blind Treatment Withdrawal (Period B)
Timepoint [90] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [91] 0 0
Percentage of Participants Achieving DLQI =1 Response During CP-690,550 Re-Treatment (Period C)
Timepoint [91] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [92] 0 0
Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)
Timepoint [92] 0 0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [93] 0 0
Percentage of Participants With DLQI =5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Timepoint [93] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [94] 0 0
Median Time to DLQI =5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Timepoint [94] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [95] 0 0
Percentage of Participants With DLQI =5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
Timepoint [95] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [96] 0 0
Median Time to DLQI =5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
Timepoint [96] 0 0
Weeks 4, 8, and 16 (Period C)
Secondary outcome [97] 0 0
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)
Timepoint [97] 0 0
Baseline and Week 24 (Period A)
Secondary outcome [98] 0 0
Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [98] 0 0
Baseline and Week 56 (Period C)
Secondary outcome [99] 0 0
Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)
Timepoint [99] 0 0
Week 24 (Period A)
Secondary outcome [100] 0 0
Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [100] 0 0
Week 56 (Period C)
Secondary outcome [101] 0 0
Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
Timepoint [101] 0 0
Baseline and Week 24 (Period A)
Secondary outcome [102] 0 0
Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [102] 0 0
Baseline and Week 56 (Period C)
Secondary outcome [103] 0 0
Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
Timepoint [103] 0 0
Week 24 (Period A)
Secondary outcome [104] 0 0
Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [104] 0 0
Week 56 (Period C)
Secondary outcome [105] 0 0
Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)
Timepoint [105] 0 0
Baseline and Weeks 4, 8, 16 and 24 (Period A)
Secondary outcome [106] 0 0
Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)
Timepoint [106] 0 0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [107] 0 0
Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)
Timepoint [107] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [108] 0 0
Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
Timepoint [108] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [109] 0 0
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)
Timepoint [109] 0 0
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcome [110] 0 0
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
Timepoint [110] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [111] 0 0
Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
Timepoint [111] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [112] 0 0
Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [112] 0 0
Baseline and Week 56 (Period C)
Secondary outcome [113] 0 0
Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
Timepoint [113] 0 0
Week 24 (Period A)
Secondary outcome [114] 0 0
Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [114] 0 0
Week 56 (Period C)
Secondary outcome [115] 0 0
Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
Timepoint [115] 0 0
Baseline and Week 24 (Period A)
Secondary outcome [116] 0 0
Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [116] 0 0
Baseline and Week 56 (Period C)
Secondary outcome [117] 0 0
Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
Timepoint [117] 0 0
Week 24 (Period A)
Secondary outcome [118] 0 0
Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
Timepoint [118] 0 0
Week 56 (Period C)
Secondary outcome [119] 0 0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)
Timepoint [119] 0 0
Weeks 4, 8, 16, and 24 (Period A)
Secondary outcome [120] 0 0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)
Timepoint [120] 0 0
Weeks 4, 8, 12, and 16 (Period B)
Secondary outcome [121] 0 0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)
Timepoint [121] 0 0
Weeks 4, 8, and 16 (Period C)

Eligibility
Key inclusion criteria
* 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
* Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
* No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-plaque or drug induced forms of psoriasis;
* Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
* Any uncontrolled significant medical condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Dr. Glenn & Partners - Kogarah
Recruitment hospital [2] 0 0
Premier Dermatology - Kogarah
Recruitment hospital [3] 0 0
Skin and Cancer Foundation - Carlton
Recruitment hospital [4] 0 0
Uniradiology - Carlton
Recruitment hospital [5] 0 0
Emeritus Research - Malvern East
Recruitment hospital [6] 0 0
Malvern Diagnostic Imaging - Malvern
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
Argentina
State/province [22] 0 0
C1114aap
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma de Buenos Aires
Country [24] 0 0
Brazil
State/province [24] 0 0
RJ
Country [25] 0 0
Brazil
State/province [25] 0 0
SP
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pleven
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sofia
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Newfoundland and Labrador
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Denmark
State/province [32] 0 0
Aarhus C
Country [33] 0 0
Denmark
State/province [33] 0 0
Hellerup
Country [34] 0 0
Denmark
State/province [34] 0 0
Svendborg
Country [35] 0 0
Finland
State/province [35] 0 0
Tampere
Country [36] 0 0
Greece
State/province [36] 0 0
Aathens
Country [37] 0 0
Greece
State/province [37] 0 0
Ioannina
Country [38] 0 0
Greece
State/province [38] 0 0
Thessaloniki
Country [39] 0 0
Netherlands
State/province [39] 0 0
Beek
Country [40] 0 0
Slovakia
State/province [40] 0 0
Bratislava
Country [41] 0 0
Slovakia
State/province [41] 0 0
Trnava
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Leytonstone
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Warwickshire
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Trial website
https://clinicaltrials.gov/study/NCT01186744
Trial related presentations / publications
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z.
Bissonnette R, Iversen L, Sofen H, Griffiths CE, Foley P, Romiti R, Bachinsky M, Rottinghaus ST, Tan H, Proulx J, Valdez H, Gupta P, Mallbris L, Wolk R. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395-406. doi: 10.1111/bjd.13551. Epub 2015 Apr 2.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01186744