Clinical trial NCT01186744: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: OPT Retreatment
OPT
chronic
moderate
severe
treatment
safety
treatment withdrawal
retreatment
retreatment withdrawal
CP-690,550
Psoriasis Vulgaris
Plaque Psoriasis
tofacitinib
Xeljanz
nail psoriasis
Jak-inhibitor
oral treatment
Pruritus
Itch
DLQI
rebound
intermittent
retreat
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
timeFrame: Weeks 4, 8 12, and 16 (Period B)
measure: Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
Secondary outcomes:
measure: Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: 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)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: 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)
timeFrame: Weeks 4 and 8 (Period B)
measure: 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)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
measure: 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)
timeFrame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
measure: 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
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: 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
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: 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
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: 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
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean PASI Score During Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean ISI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
measure: 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)
timeFrame: Baseline and Week 24 (Period A)
measure: Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Week 56 (Period C)
measure: Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)
timeFrame: Week 24 (Period A)
measure: Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Week 56 (Period C)
measure: Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Week 24 (Period A)
measure: Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Week 56 (Period C)
measure: Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
timeFrame: Week 24 (Period A)
measure: Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Week 56 (Period C)
measure: Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)
timeFrame: Baseline and Weeks 4, 8, 16 and 24 (Period A)
measure: Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Baseline and Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: 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)
timeFrame: Baseline and Weeks 4, 8, and 16 (Period C)
measure: 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
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Week 56 (Period C)
measure: Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
timeFrame: Week 24 (Period A)
measure: Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Week 56 (Period C)
measure: Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
timeFrame: Baseline and Week 24 (Period A)
measure: Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Baseline and Week 56 (Period C)
measure: Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
timeFrame: Week 24 (Period A)
measure: Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
timeFrame: Week 56 (Period C)
measure: Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)
timeFrame: Weeks 4, 8, 16, and 24 (Period A)
measure: Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)
timeFrame: Weeks 4, 8, 12, and 16 (Period B)
measure: Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)
timeFrame: Weeks 4, 8, and 16 (Period C)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Associates In Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: Expresscare Medical
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Longmont
country: United States
facility: Longmont Clinic, PC
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Louisville
country: United States
facility: DMIA
state: Kentucky
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Louisville
country: United States
facility: Quest Diagnostics
state: Kentucky
city: Beverly
country: United States
facility: Northeast Dermatology Associates
state: Massachusetts
city: Haverhill
country: United States
facility: ActivMed Practices and Research, Inc.
state: Massachusetts
city: Clinton Township
country: United States
facility: Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: Dermatology Associates
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Group, PA
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Imaging
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Triad Dermatology, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Jewish Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Charleston
country: United States
facility: Office of Marta T. Hampton, MD
state: South Carolina
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
city: Greer
country: United States
facility: Office of John Michael Humeniuk, MD
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: San Antonio
country: United States
facility: Office of Stephen Miller, MD, PA
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Dermatologicas
state: C1114aap
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Dermatologicas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: IMAI (Instituto Medico de Asistencia e Investigaciones)
city: Kogarah
country: Australia
facility: Dr. Glenn & Partners
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Dermatology
state: New South Wales
city: Carlton
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
city: Carlton
country: Australia
facility: Uniradiology
state: Victoria
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Malvern
country: Australia
facility: Malvern Diagnostic Imaging
state: Victoria
city: Rio de Janeiro
country: Brazil
facility: Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ
state: RJ
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
city: Pleven
country: Bulgaria
facility: Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
city: Sofia
country: Bulgaria
facility: Tsentar za kozhno-venericheski zaboliavania� EOOD
city: Sofia
country: Bulgaria
facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
city: Sofia
country: Bulgaria
facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
city: Sofia
country: Bulgaria
facility: MBAL na Voennomeditsinska akademia- Sofia
city: Vancouver
country: Canada
facility: Derm Research @ 888 Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Department of Dermatology and Skin Science
state: British Columbia
city: Saint John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc.
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Aarhus C
country: Denmark
facility: Department of Dermatology, Aarhus University Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Svendborg
country: Denmark
facility: Hudklinikken
city: Tampere
country: Finland
facility: Tampere University Hospital, Department of Dermatology and Venreology
city: Aathens
country: Greece
facility: Dermatology Department, Andreas Sygros Hospital
city: Ioannina
country: Greece
facility: University Hospital of Ioannina/Dermatology Department
city: Thessaloniki
country: Greece
facility: "Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik
city: Beek
country: Netherlands
facility: PT & R
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica, Bratislava
city: Trnava
country: Slovakia
facility: Fakultna Nemocnica Trnava
city: London
country: United Kingdom
facility: Whipps Cross University Hospital, Department of Dermatology
state: Leytonstone
city: Nuneaton
country: United Kingdom
facility: Department of Dermatology
state: Warwickshire
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.