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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01276639
First received: January 12, 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: Phase 3 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 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:
  • 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 at Week 16 [ Time Frame: baseline, Week 16 ] [ Designated as safety issue: No ]
  • Physician Global Assessment (PGA) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality 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 (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 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: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 75(PASI75) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: 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 Aera 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 component scores [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Physicians Area and Severity Index (PASI) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and percent change from 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) [ 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 change from baseline Nail Psoriasis Severity Index (NAPSI) and number of affected nails in participants with nail psoriasis at baseline [ Time Frame: Baseline, Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis at baseline [ Time Frame: 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 subjects 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: 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: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4,16,28,52 ] [ 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 ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Weeks 4,16,28,52 ] [ 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 4,16,28,52 ] [ 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: 905
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: ActiveTreatment 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:

  • Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
  • a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
  • 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: NCT01276639

  Hide Study Locations
Locations
United States, Alabama
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
United States, California
University of California, Irvine - Dermatology Research
Irvine, California, United States, 92697
Skin Surgery Medical Group, Inc.
San Diego, California, United States, 92117
Clinical Science Institute
Santa Monica, California, United States, 90404
United States, Colorado
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
United States, Connecticut
The Savin Center, P.C.
New Haven, Connecticut, United States, 06511
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
Academic Alliance in Dermatology
Tampa, Florida, United States, 33609
United States, Georgia
Atlanta Dermatology, Vein & Research Center, P.C.
Alpharetta, Georgia, United States, 30022
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States, 30327
MedaPhase Inc.
Newnan, Georgia, United States, 30263
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
Boston, Massachusetts, United States, 02114
United States, Nebraska
Skin Specialists, P.C.
Omaha, Nebraska, United States, 68144
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Raleigh Radiology Blue Ridge
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
United States, Oregon
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
University of Pittsburgh Medical Center - Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Dermatology Associates of Knoxville, PC
Knoxville, Tennessee, United States, 37917
United States, Texas
Modern Research Associates, PLLC
Dallas, Texas, United States, 75231
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77030
United States, Washington
Rockwood Research Center
Spokane, Washington, United States, 99202
Rockwood Dermatology Center
Spokane, Washington, United States, 99202
Wenatchee Valley Medical Center - Clinical Research Department
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Madison Skin and Research, Inc.
Madison, Wisconsin, United States, 53719
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Newfoundland and Labrador
Dr. Zohair Tomi PMC Inc.
St. John's, Newfoundland and Labrador, Canada, A1B 4S8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Ultranova Skincare
Barrie, Ontario, Canada, L4M 6L2
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1A8
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Oakville Dermatology Laser Centre
Oakville, Ontario, Canada, L6J 7W5
Office of Dr. Michael Robern
Ottawa, Ontario, Canada, K2G 6E2
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
Canada
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
Quebec, Canada, G1J 1X7
Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, Atlantico, Colombia, 0000
Riesgo de Fractura S.A
Bogot, Cundinamarca, Colombia, 0000
Germany
Charite - Universitaetsmedizin Berlin
Berlin, Germany, 10117
Aerztehaus "Rudolf Virchow"
Berlin, Germany, 13055
Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn
Bonn, Germany, 53105
Universitaetsklinik Carl Gustav Carus
Dresden, Germany, 01307
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Klinische Forschung Schwerin GmbH
Schwerin, Germany, 19055
Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde
Vechta, Germany, 49377
Facharzt fuer Dermatologie und Venerologie, Allergologie
Wuppertal, Germany, 42275
Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
Kecskemet, Hungary, 6000
Josa Andras Oktatokorhaz, Borgyogyaszat
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika
Pecs, Hungary, 7624
Japan
Gunma University Hospital
Maebashi-shi, Gunma, Japan
JR Sapporo hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Chuo-ku, Kobe, Japan
Kumamoto University Hospital
Kumamoto-shi, Kumamoto, Japan
Social Insurance Chuo General Hospital
Shinjyuku-ku, Tokyo, Japan
Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo Leon, Mexico, 64460
Poland
Poznanski Osrodek Medyczny
Poznan, Poland, 60-773
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
Szczecin, Poland, 70-111
Oddzial Dermatologiczny
Wroclaw, Poland, 51-124
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw, Poland, 50-368
Serbia
Clinical Hospital Center Zvezdara
Belgrade, Serbia, 11000
Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 110
Ukraine
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"
Simferopol, Crimea, Ukraine, 95006
Dept of Dermatology, Infectious and Parasitic Skin Diseases
Kharkiv, Ukraine, 61057
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, Ukraine, 01032
Ternopil Regional Clinical Dermatovenerologic Dispensary
Ternopil, Ukraine, 46006
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: NCT01276639     History of Changes
Other Study ID Numbers: A3921078
Study First Received: January 12, 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 September 18, 2014