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
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
1 other identifier
interventional
666
12 countries
87
Brief Summary
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2014
CompletedDecember 26, 2018
December 1, 2018
2.3 years
August 20, 2010
January 27, 2014
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Weeks 4, 8 12, and 16 (Period B)
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).
Weeks 4, 8, 12, and 16 (Period B)
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.
Baseline and Weeks 4, 8, and 16 (Period C)
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)
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).
Baseline and Weeks 4, 8, and 16 (Period C)
Secondary Outcomes (121)
Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
Weeks 4, 8, 16, and 24 (Period A)
Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
Weeks 4, 8, 16, and 24 (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)
Weeks 4, 8, 16, and 24 (Period A)
Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Weeks 4, 8, 12, and 16 (Period B)
Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Weeks 4, 8, 12, and 16 (Period B)
- +116 more secondary outcomes
Study Arms (4)
Active Treatment (10 mg) BID / Placebo BID
EXPERIMENTALContinuous 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
Active Treatment (10 mg) BID
EXPERIMENTALContinuous active treatment (CP-690,550) for 56 weeks
Active Treatment (5 mg) BID / Placebo BID
EXPERIMENTALContinuous 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
Active Treatment (5 mg) BID
EXPERIMENTALContinuous active treatment (CP-690,550) for 56 weeks
Interventions
10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (87)
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Associates In Research, Inc.
Fresno, California, 93720, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Expresscare Medical
Los Angeles, California, 90045, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
University of California San Francisco
San Francisco, California, 94118, United States
Longmont Clinic, PC
Longmont, Colorado, 80501, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Florida Academic Dermatology Center
Miami, Florida, 33136, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Park Avenue Dermatology, PA
Orange Park, Florida, 32073, United States
Ameriderm Research
Ormond Beach, Florida, 32174, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Springfield Clinic, LLP
Springfield, Illinois, 62703, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
DMIA
Louisville, Kentucky, 40207, United States
DermResearch, PLLC
Louisville, Kentucky, 40217, United States
Quest Diagnostics
Louisville, Kentucky, 40217, United States
Northeast Dermatology Associates
Beverly, Massachusetts, 01915, United States
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, 01830, United States
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Dermatology Associates
Wilmington, North Carolina, 28401, United States
New Hanover Medical Group, PA
Wilmington, North Carolina, 28401, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28401, United States
Piedmont Imaging
Winston-Salem, North Carolina, 27103, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Triad Dermatology, PA
Winston-Salem, North Carolina, 27103, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
Office of Marta T. Hampton, MD
Charleston, South Carolina, 29407, United States
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414, United States
Office of John Michael Humeniuk, MD
Greer, South Carolina, 29650, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
Office of Stephen Miller, MD, PA
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Centro de Investigaciones Dermatologicas
Buenos Aires, C1114aap, Argentina
Centro de Investigaciones Dermatologicas
Buenos Aires, C1114AAP, Argentina
IMAI (Instituto Medico de Asistencia e Investigaciones)
Buenos Aires, C1425AWC, Argentina
Dr. Glenn & Partners
Kogarah, New South Wales, 2217, Australia
Premier Dermatology
Kogarah, New South Wales, 2217, Australia
Skin and Cancer Foundation
Carlton, Victoria, 3053, Australia
Uniradiology
Carlton, Victoria, 3053, Australia
Malvern Diagnostic Imaging
Malvern, Victoria, 3144, Australia
Emeritus Research
Malvern East, Victoria, 3145, Australia
Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ
Rio de Janeiro, Rio de Janeiro, 22470-220, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900, Brazil
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven
Pleven, 5800, Bulgaria
Tsentar za kozhno-venericheski zaboliavania� EOOD
Sofia, 1404, Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia
Sofia, 1407, Bulgaria
Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia
Sofia, 1431, Bulgaria
MBAL na Voennomeditsinska akademia- Sofia
Sofia, 1606, Bulgaria
Derm Research @ 888 Inc.
Vancouver, British Columbia, V5Z 3Y1, Canada
UBC Department of Dermatology and Skin Science
Vancouver, British Columbia, V5Z 4E8, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Dermatrials Research
Hamilton, Ontario, L8N 1V6, Canada
Windsor Clinical Research
Windsor, Ontario, N8W 5L7, Canada
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7, Canada
Department of Dermatology, Aarhus University Hospital
Aarhus C, 8000, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Hudklinikken
Svendborg, 5700, Denmark
Tampere University Hospital, Department of Dermatology and Venreology
Tampere, 33521, Finland
Dermatology Department, Andreas Sygros Hospital
Aathens, 16121, Greece
University Hospital of Ioannina/Dermatology Department
Ioannina, 45500, Greece
"Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik
Thessaloniki, 56403, Greece
PT & R
Beek, 6191 JW, Netherlands
Univerzitna Nemocnica, Bratislava
Bratislava, 813 69, Slovakia
Fakultna Nemocnica Trnava
Trnava, 917 75, Slovakia
Whipps Cross University Hospital, Department of Dermatology
London, Leytonstone, E11 1NR, United Kingdom
Department of Dermatology
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
Salford Royal NHS Foundation Trust
Manchester, M6 8HD, United Kingdom
Related Publications (2)
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.
PMID: 32816215DERIVEDBissonnette 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.
PMID: 25418186DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Clinical interpretation regarding sub-phenotypes of psoriasis (e.g., scalp psoriasis) should not be made based on the reported assessments by body regions. For example, the body region of head does not reflect solely scalp psoriasis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2010
First Posted
August 23, 2010
Study Start
September 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
December 26, 2018
Results First Posted
June 4, 2014
Record last verified: 2018-12