A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01309737
First received: March 4, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: Placebo/CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physician's Global Assessment (PGA)response, ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of participants achieving at least a 75% reduction in Psoriasis Area and Severity Index relative to baseline at Week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) total score to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment (PGA)response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Index (DLQI) total score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 in participants with nail psoriasis at baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Physicians Global Assessment (PGA) response at Week 52 among participants achieving PGA response at Week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Severity Index 75 (PASI75) response at Week 52 among participants achieving PASI75 response at Week 16. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Severity Index 90 (PASI90) response at Week 52 among participants achieving PASI90 response at Week 16. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Physicians Global Assessment (PGA) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment (PGA) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Psoriasis Area and Severity Index (PASI) and PASI component scores [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40 and 52 ] [ Designated as safety issue: No ]
  • Actual and change in baseline in Body Surface Area (BSA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (PASI50 and PASI90, respectively) at various time points through Week 52. [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants with a PASI score > or equal to 125% of the baseline PASI score at any time point through Week 52 [ Time Frame: Weeks 2,4,8,12,16,20,28,40, 52 ] [ Designated as safety issue: No ]
  • Actual and percent change from baseline in Nail Psoriasis Severity Index (NAPSI) and number of affected nails in participants [ Time Frame: Baseline, Weeks 8,16,20,28,40 and 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis at baseline. [ Time Frame: Baseline, Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving at least 75% and 100% reduction in Nail Psoriasis Severity Index (NAPSI) relative to baseline (NAPSI75 and NAPSI100, respectively) in participants with nail psoriasis at baseline. [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Itch Severity Item (ISI) score [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Short Form 36 Health Survey (SF-36) - Version 2, Acute [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Joint Pain Assessment (JPA) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Euro Qol 5 Dimensions (EQ-5D) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps HCRU) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Family Dermatology Life Quality Index (FDLQI) [ Time Frame: Weeks 16,52 ] [ Designated as safety issue: No ]

Enrollment: 967
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment 10 mg BID Drug: CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
Experimental: Active Treatment 5 mg BID Drug: CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
Placebo Comparator: Placebo Treatment Drug: Placebo/CP-690,550
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)
Drug: Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309737

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States, 93309
University of California San Diego
La Jolla, California, United States, 92037
Expresscare Medical (X-Rays only)
Los Angeles, California, United States, 90045
Dermatology Research Associates
Los Angeles, California, United States, 90045
MedDerm Associates
San Diego, California, United States, 92103
University of California San Diego
San Diego, California, United States, 92122
Healthcare Partners Medical Group
Torrance, California, United States, 90503
United States, Florida
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
United States, Georgia
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States, 31217
United States, Illinois
Sherman Immediate Care Center (Imaging Only)
Algonquin, Illinois, United States, 60102
Schaumburg Dermatology
Schaumburg, Illinois, United States, 60194
NorthShore University HealthSystem - Division of Dermatology
Skokie, Illinois, United States, 60077
Dundee Dermatology
West Dundee, Illinois, United States, 60118
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Somerset Skin Centre - Dermcenter
Troy, Michigan, United States, 48084
United States, Minnesota
University of Minnesota - Department of Dermatology
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis University - Department of Dermatology
Saint Louis, Missouri, United States, 63104
Central Dermatology, PC
St. Louis, Missouri, United States, 63117
United States, Nevada
Bettencourt Skin Center
Henderson, Nevada, United States, 89074
United States, New Hampshire
Dartmouth Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
The Rockefeller University
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Radiant Research, Inc.
Columbus, Ohio, United States, 43212
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
Austin Dermatology Associates
Austin, Texas, United States, 78705
InSight Diagnostic Center
Dallas, Texas, United States, 75243
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States, 75230
Center for Clinical Studies
Houston, Texas, United States, 77030
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Progressive Clinical Research, PA
San Antonio, Texas, United States, 78229
Office of Mark S. Lee, MD
San Antonio, Texas, United States, 78229
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, Alberta
Northwest Dermatology & Laser Centre
Calgary, Alberta, Canada, T3G 0B4
Kirk Barber Research
Calgary, Alberta, Canada, T2S 3B3
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
PerCuro Clinical Research Ltd
Victoria, British Columbia, Canada, V8V 3P9
Practice office of John D. Amiss MD
Victoria, British Columbia, Canada, V8V 3M9
Canada, Newfoundland and Labrador
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z4
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
CCA Medical Research Corporation
Ajax, Ontario, Canada, L1S 7K8
Co-Medica Research Network Inc.
Courtice, Ontario, Canada, L1E 3C3
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Oshawa Clinic
Oshawa, Ontario, Canada, L1H 1B9
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 1Z2
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Siena Medical Research
Montreal, Quebec, Canada, H3Z 2S6
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia, 0000
Germany
Facharzt fuer Dermatologie und Allergologie
Berlin, Germany, 10435
Klinische Forschung Berlin-Buch GmbH
Berlin, Germany, 13125
Dres.Kirsten Prepeneit und Volker Streit
Buchholz, Germany, 21244
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt/Main, Germany, 60590
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, Germany, 06120
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, Germany, 63450
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
Luebeck, Germany, 23538
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, Germany, 15831
Wilhelm Fresenius Klinik
Wiesbaden/ Bierstadt, Germany, 65191
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
Witten, Germany, 58453
Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
Szekszard, Hungary, 7100
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
Szombathely, Hungary, 9700
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
Veszprem, Hungary, 8200
Mexico
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
Mexico, D.f., Mexico, 06700
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan, Jalisco, Mexico, 45190
Centro Medico San Lucas
Monterrey, Nuevo Leon, Mexico, 64710
Poland
Specjalistyczne Gabinety Lekarskie "Dermed�
Lodz, Poland, 90-265
MTZ Clinical Research Sp. z o.o.
Warszawa, Poland, 02-106
Klinika Dermatologii Wojskowy Instytut Medyczny
Warszawa, Poland, 04-141
Puerto Rico
The Office of Dr. Alma M. Cruz, MD.
Carolina, Puerto Rico, 00985
Serbia
Military Medical Academy
Belgrade, Serbia, 11000
Taiwan
Chang Gung Memorial Hospital Kaohsiung branch
Niao-Sung Hsiang, Kaohsiung County, Taiwan, 833
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, Taiwan, 333
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 235
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Ukraine
MIHC Kharkiv City Dermatovenerologic Dispensary #2
Kharkiv, Ukraine, 61038
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, Ukraine, 01032
Lugansk Regional Dermatovenerologic Dispensary
Lugansk, Ukraine, 91047
Lviv regional municipal dermatovenerologic dispensary,
Lviv, Ukraine, 79013
Department of dermatology and venereology of Odessa National Medical University
Odessa, Ukraine, 65006
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01309737     History of Changes
Other Study ID Numbers: A3921079
Study First Received: March 4, 2011
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic
severe
moderate
treatment
safety
efficacy
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014