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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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Horizon Research Group, Inc.
Radiant Research, Inc.
Center for Dermatology Clinical Research, Inc.
Associates In Research, Inc.
Dermatology Research Associates
Expresscare Medical
Dermatology Specialists, Inc.
University of California San Francisco
Longmont Clinic, PC
New England Research Associates, LLC
Florida Academic Dermatology Center
International Dermatology Research, Inc.
Park Avenue Dermatology, PA
Ameriderm Research
Miami Research Associates
Altman Dermatology Associates
Springfield Clinic, LLP
Springfield Clinic
Deaconess Clinic Downtown
DMIA
DermResearch, PLLC
Quest Diagnostics
Northeast Dermatology Associates
ActivMed Practices and Research, Inc.
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
Minnesota Clinical Study Center
Comprehensive Clinical Research
Duke University Medical Center
Dermatology Consulting Services
Dermatology Associates
New Hanover Medical Group, PA
New Hanover Medical Research
PMG Research of Wilmington LLC
Piedmont Imaging
Piedmont Medical Research
Triad Dermatology, PA
Jewish Hospital
Radiant Research, Inc.
University Hospitals Case Medical Center
Oregon Medical Research Center, PC
Rhode Island Hospital
Medical Research South, LLC
Office of Marta T. Hampton, MD
Dermatology & Laser Center of Charleston
Office of John Michael Humeniuk, MD
Radiant Research, Inc.
Dermatology Research Associates
Office of Stephen Miller, MD, PA
Center for Clinical Studies
Mountain State Clinical Research
Centro de Investigaciones Dermatologicas
Centro de Investigaciones Dermatologicas
IMAI (Instituto Medico de Asistencia e Investigaciones)
Dr. Glenn & Partners
Premier Dermatology
Skin and Cancer Foundation
Uniradiology
Emeritus Research
Malvern Diagnostic Imaging
Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
Tsentar za kozhno-venericheski zaboliavania� EOOD
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
MBAL na Voennomeditsinska akademia- Sofia
Derm Research @ 888 Inc.
UBC Department of Dermatology and Skin Science
Nexus Clinical Research
NewLab Clinical Research Inc.
Dermatrials Research
Windsor Clinical Research
Innovaderm Research Inc
Centre de Recherche Dermatologique du Quebec metropolitain
Department of Dermatology, Aarhus University Hospital
Gentofte Hospital
Hudklinikken
Tampere University Hospital, Department of Dermatology and Venreology
Dermatology Department, Andreas Sygros Hospital
University Hospital of Ioannina/Dermatology Department
"Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik
PT & R
Univerzitna Nemocnica, Bratislava
Fakultna Nemocnica Trnava
Whipps Cross University Hospital, Department of Dermatology
Department of Dermatology
Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Active Treatment (10 mg) BID / Placebo BID

Active Treatment (10 mg) BID

Active Treatment (5 mg) BID / Placebo BID

Active Treatment (5 mg) BID

Arm Description

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

Continuous active treatment (CP-690,550) for 56 weeks

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

Continuous active treatment (CP-690,550) for 56 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.

Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).

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)

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.

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)

Secondary Outcome Measures

Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.

Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)

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)

PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)

Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)

Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

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)

The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.

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)

The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.

Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)

Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.

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)

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

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

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

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

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

PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.

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)

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

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

Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)

PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.

Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)

PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.

Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)

Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)

PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.

Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)

Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)

Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)

Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)

Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)

Baseline defined as the last observation up to first dosing date in Period A.

Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)

Baseline defined as the last observation up to first dosing date in Period B.

Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)

Baseline was defined as the last observation until first dosing date in Period C.

Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)

Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)

Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)

Baseline defined as the last observation up to first dosing date in Period A.

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)

Baseline defined as the last observation up to first dosing date in Period B.

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)

Baseline defined as the last observation up to first dosing date in Period C.

Mean PASI Score During Initial CP-690,550 Treatment (Period A)

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)

Mean PASI Score During the CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)

Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)

Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)

Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)

Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A

PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A

Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A

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)

PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.

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)

Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)

PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)

Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)

The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.

Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)

Mean ISI Score During the CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)

Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)

Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)

Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)

Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)

Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)

Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)

ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response

Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)

ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response

Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)

ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response

Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)

ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response

Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)

Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)

Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)

Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)

Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).

Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)

Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)

Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)

Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)

Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)

Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)

Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.

Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)

Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

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)

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)

Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)

Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)

Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe

Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)

Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)

Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)

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)

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

Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)

Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)

Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)

Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)

Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)

Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)

Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)

Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)

Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)

Full Information

NCT ID

NCT01186744

First Posted

August 20, 2010

Last Updated

December 3, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01186744

Brief 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

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

666 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment (10 mg) BID / Placebo BID

Arm Type

Experimental

Arm Description

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

Arm Title

Active Treatment (10 mg) BID

Arm Type

Experimental

Arm Description

Continuous active treatment (CP-690,550) for 56 weeks

Arm Title

Active Treatment (5 mg) BID / Placebo BID

Arm Type

Experimental

Arm Description

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

Arm Title

Active Treatment (5 mg) BID

Arm Type

Experimental

Arm Description

Continuous active treatment (CP-690,550) for 56 weeks

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg oral BID

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

5 mg oral BID

Primary Outcome Measure Information:

Title

Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)

Description

Time Frame

Weeks 4, 8 12, and 16 (Period B)

Title

Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Secondary Outcome Measure Information:

Title

Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)

Description

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

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)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)

Description

Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)

Description

Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

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)

Description

Time Frame

Weeks 4 and 8 (Period B)

Title

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)

Description

The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)

Description

Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.

Time Frame

Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)

Title

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)

Title

Description

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Description

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

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)

Description

PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

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)

Title

Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)

Description

Baseline defined as the last observation up to first dosing date in Period A.

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)

Description

Baseline defined as the last observation up to first dosing date in Period B.

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)

Description

Baseline was defined as the last observation until first dosing date in Period C.

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)

Description

Baseline defined as the last observation up to first dosing date in Period A.

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)

Description

Baseline defined as the last observation up to first dosing date in Period B.

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)

Description

Baseline defined as the last observation up to first dosing date in Period C.

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean PASI Score During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean PASI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

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)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

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)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean ISI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)

Description

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.

Time Frame

Baseline and Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)

Description

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)

Description

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.

Time Frame

Weeks 4, 8, and 16 (Period C)

Title

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)

Description

Time Frame

Baseline and Week 24 (Period A)

Title

Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)

Description

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Time Frame

Baseline and Week 56 (Period C)

Title

Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)

Description

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Time Frame

Week 24 (Period A)

Title

Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)

Description

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.

Time Frame

Week 56 (Period C)

Title

Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Week 24 (Period A)

Title

Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Week 56 (Period C)

Title

Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Week 24 (Period A)

Title

Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Week 56 (Period C)

Title

Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Baseline and Weeks 4, 8, 16 and 24 (Period A)

Title

Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)

Description

Time Frame

Baseline and Weeks 4, 8, 12, and 16 (Period B)

Title

Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Description

Time Frame

Baseline and Weeks 4, 8, and 16 (Period C)

Title

Description

Time Frame

Weeks 4, 8, 12, and 16 (Period B)

Title

Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)

Description

Time Frame

Weeks 4, 8, 16, and 24 (Period A)

Title

Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Week 56 (Period C)

Title

Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)

Description

Time Frame

Week 24 (Period A)

Title

Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Week 56 (Period C)

Title

Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)

Description

Time Frame

Baseline and Week 24 (Period A)

Title

Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Baseline and Week 56 (Period C)

Title

Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)

Description

Time Frame

Week 24 (Period A)

Title

Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)

Description

Time Frame

Week 56 (Period C)

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Horizon Research Group, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Radiant Research, Inc.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Center for Dermatology Clinical Research, Inc.

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Associates In Research, Inc.

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Expresscare Medical

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Dermatology Specialists, Inc.

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Facility Name

Longmont Clinic, PC

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Florida Academic Dermatology Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

International Dermatology Research, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Park Avenue Dermatology, PA

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Ameriderm Research

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Miami Research Associates

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Altman Dermatology Associates

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Springfield Clinic, LLP

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Springfield Clinic

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Deaconess Clinic Downtown

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

DMIA

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Quest Diagnostics

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Northeast Dermatology Associates

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

ActivMed Practices and Research, Inc.

City

Haverhill

State/Province

Massachusetts

ZIP/Postal Code

01830

Country

United States

Facility Name

Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

City

Clinton Township

State/Province

Michigan

ZIP/Postal Code

48038

Country

United States

Facility Name

Minnesota Clinical Study Center

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Dermatology Consulting Services

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Dermatology Associates

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

New Hanover Medical Group, PA

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

New Hanover Medical Research

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

PMG Research of Wilmington LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Piedmont Imaging

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Piedmont Medical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Triad Dermatology, PA

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Jewish Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Radiant Research, Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Oregon Medical Research Center, PC

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Medical Research South, LLC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Office of Marta T. Hampton, MD

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Dermatology & Laser Center of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Office of John Michael Humeniuk, MD

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Radiant Research, Inc.

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Dermatology Research Associates

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Office of Stephen Miller, MD, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Mountain State Clinical Research

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Centro de Investigaciones Dermatologicas

City

Ciudad Autonoma de Buenos Aires

State/Province

C1114aap

Country

Argentina

Facility Name

Centro de Investigaciones Dermatologicas

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1114AAP

Country

Argentina

Facility Name

IMAI (Instituto Medico de Asistencia e Investigaciones)

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1425AWC

Country

Argentina

Facility Name

Dr. Glenn & Partners

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Premier Dermatology

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Skin and Cancer Foundation

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Uniradiology

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Emeritus Research

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Malvern Diagnostic Imaging

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22470-220

Country

Brazil

Facility Name

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

05403-900

Country

Brazil

Facility Name

Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Tsentar za kozhno-venericheski zaboliavania� EOOD

City

Sofia

ZIP/Postal Code

1404

Country

Bulgaria

Facility Name

Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

MBAL na Voennomeditsinska akademia- Sofia

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Derm Research @ 888 Inc.

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 3Y1

Country

Canada

Facility Name

UBC Department of Dermatology and Skin Science

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E8

Country

Canada

Facility Name

Nexus Clinical Research

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 5E8

Country

Canada

Facility Name

NewLab Clinical Research Inc.

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 2H5

Country

Canada

Facility Name

Dermatrials Research

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1V6

Country

Canada

Facility Name

Windsor Clinical Research

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 5L7

Country

Canada

Facility Name

Innovaderm Research Inc

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2K 4L5

Country

Canada

Facility Name

Centre de Recherche Dermatologique du Quebec metropolitain

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Department of Dermatology, Aarhus University Hospital

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Gentofte Hospital

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Hudklinikken

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Tampere University Hospital, Department of Dermatology and Venreology

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Dermatology Department, Andreas Sygros Hospital

City

Aathens

ZIP/Postal Code

16121

Country

Greece

Facility Name

University Hospital of Ioannina/Dermatology Department

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

"Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

PT & R

City

Beek

ZIP/Postal Code

6191 JW

Country

Netherlands

Facility Name

Univerzitna Nemocnica, Bratislava

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Fakultna Nemocnica Trnava

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Facility Name

Whipps Cross University Hospital, Department of Dermatology

City

London

State/Province

Leytonstone

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Department of Dermatology

City

Nuneaton

State/Province

Warwickshire

ZIP/Postal Code

CV10 7DJ

Country

United Kingdom

Facility Name

Salford Royal NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32816215

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. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Results Reference

derived

PubMed Identifier

25418186

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921111&StudyName=A%20Phase%203%2C%20Multi-Site%2C%20Randomized%2C%20Mixed-Blind%2C%20Parallel-Group%20Treatment%20Withdrawal%20And%20Re-Treatment%20Study%20Of%20The%20Efficacy%20And%20Safety%20Of%202%20Oral%20Doses%20Of%20CP-690%2C550%20In%20Subjects%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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