A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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
960
11 countries
94
Brief Summary
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 19, 2014
CompletedSeptember 19, 2014
September 1, 2014
2.1 years
March 4, 2011
July 24, 2014
September 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
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 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16
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. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Week 16
Secondary Outcomes (51)
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
Baseline, Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16
Week 16
Dermatology Life Quality Index (DLQI) Total Score
Baseline
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16
Baseline, Week 4,16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4
Week 4
- +46 more secondary outcomes
Study Arms (3)
Active Treatment 10 mg BID
EXPERIMENTALActive Treatment 5 mg BID
EXPERIMENTALPlacebo Treatment
PLACEBO COMPARATORInterventions
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Eligibility Criteria
You may qualify if:
- years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
- A Psoriasis Area and Severity Index (PASI) score of 12 or greater
- Are considered to be candidates for systemic or light therapy
- Have no evidence of active or latent tuberculosis
You may not qualify if:
- Non-plaque or drug-induced forms of psoriasis
- Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
- Any uncontrolled significant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (94)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
University of California San Diego
La Jolla, California, 92037, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Expresscare Medical (X-Rays only)
Los Angeles, California, 90045, United States
MedDerm Associates
San Diego, California, 92103, United States
University of California San Diego
San Diego, California, 92122, United States
Healthcare Partners Medical Group
Torrance, California, 90503, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217, United States
Sherman Immediate Care Center (Imaging Only)
Algonquin, Illinois, 60102, United States
Schaumburg Dermatology
Schaumburg, Illinois, 60194, United States
NorthShore University HealthSystem - Division of Dermatology
Skokie, Illinois, 60077, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Hudson Dermatology
Evansville, Indiana, 47714, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre - Dermcenter
Troy, Michigan, 48084, United States
University of Minnesota - Department of Dermatology
Minneapolis, Minnesota, 55455, United States
Saint Louis University - Department of Dermatology
St Louis, Missouri, 63104, United States
Central Dermatology, PC
St Louis, Missouri, 63117, United States
Bettencourt Skin Center
Henderson, Nevada, 89074, United States
Dartmouth Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, 03756, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
The Rockefeller University
New York, New York, 10065, United States
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, 27514, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, 75230, United States
InSight Diagnostic Center
Dallas, Texas, 75243, United States
Center for Clinical Studies
Houston, Texas, 77030, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Office of Mark S. Lee, MD
San Antonio, Texas, 78229, United States
Progressive Clinical Research, PA
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Kirk Barber Research
Calgary, Alberta, T2S 3B3, Canada
Northwest Dermatology & Laser Centre
Calgary, Alberta, T3G 0B4, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7, Canada
Practice office of John D. Amiss MD
Victoria, British Columbia, V8V 3M9, Canada
PerCuro Clinical Research Ltd
Victoria, British Columbia, V8V 3P9, Canada
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z4, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
CCA Medical Research Corporation
Ajax, Ontario, L1S 7K8, Canada
Co-Medica Research Network Inc.
Courtice, Ontario, L1E 3C3, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
Oshawa Clinic
Oshawa, Ontario, L1H 1B9, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2, Canada
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6, Canada
Siena Medical Research
Montreal, Quebec, H3Z 2S6, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 0000, Colombia
Facharzt fuer Dermatologie und Allergologie
Berlin, 10435, Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, 13125, Germany
Dres.Kirsten Prepeneit und Volker Streit
Buchholz, 21244, Germany
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60590, Germany
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, 06120, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, 63450, Germany
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
Lübeck, 23538, Germany
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, 15831, Germany
Wilhelm Fresenius Klinik
Wiesbaden/ Bierstadt, 65191, Germany
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
Witten, 58453, Germany
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
Szekszárd, 7100, Hungary
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
Szombathely, 9700, Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
Veszprém, 8200, Hungary
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
México, D.f., 06700, Mexico
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan, Jalisco, 45190, Mexico
Centro Medico San Lucas
Monterrey, Nuevo León, 64710, Mexico
Specjalistyczne Gabinety Lekarskie "Dermed�
Lodz, 90-265, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Klinika Dermatologii Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
The Office of Dr. Alma M. Cruz, MD.
Carolina, 00985, Puerto Rico
Military Medical Academy
Belgrade, 11000, Serbia
Chang Gung Memorial Hospital Kaohsiung branch
Niao-Sung Hsiang, Kaohsiung County, 833, Taiwan
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, 333, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
MIHC Kharkiv City Dermatovenerologic Dispensary #2
Kharkiv, Ukraine, 61038, Ukraine
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, 01032, Ukraine
Lugansk Regional Dermatovenerologic Dispensary
Luhansk, 91047, Ukraine
Lviv regional municipal dermatovenerologic dispensary,
Lviv, 79013, Ukraine
Department of dermatology and venereology of Odessa National Medical University
Odesa, 65006, Ukraine
Related Publications (4)
Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
PMID: 38696034DERIVEDPanaccione 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: 32816215DERIVEDMerola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.
PMID: 28396102DERIVEDPapp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.
PMID: 26149717DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
March 4, 2011
First Posted
March 7, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 19, 2014
Results First Posted
September 19, 2014
Record last verified: 2014-09