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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Psoriasis
Both
Psoriasis
Trial Information
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
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.
Type of Study:
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
Outcome Measure:
Proportion of participants maintaining a PASI75 response (at least a 75% reduction PASI relative to baseline) during the 16 week double blind active or placebo treatment period (CP- 690,550 treatment withdrawal; Period B)
Outcome Time Frame:
Weeks 28,32,36,40
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A3921111
NCT ID:
NCT01186744
Start Date:
September 2010
Completion Date:
January 2013
Related Keywords:
- Psoriasis
- chronic
- moderate
- severe
- treatment
- safety
- treatment withdrawal
- retreatment
- CP-690
- 550
- Psoriasis Vulgaris
- Plaque Psoriasis
- Psoriasis
Name | Location |
|---|---|
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of California San Francisco | San Francisco, California 941104206 |
| Jewish Hospital | Cincinnati, Ohio 45236 |
| Springfield Clinic, LLP | Springfield, Illinois 62703 |
| Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
| Center For Clinical Studies | Houston, Texas 77030 |
| Associates In Research, Inc. | Fresno, California 93720 |
| New England Research Associates, Llc | Trumbull, Connecticut 06611 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
| Miami Research Associates | Miami, Florida 33173 |
| Park Avenue Dermatology, PA | 1543 Kingsley Ave, Bldg 1 and 16 Orange Park, Florida 32073 |
| Comprehensive Clinical Research | Berlin, New Jersey 08009 |
| Springfield Clinic | Springfield, Illinois 62703 |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Piedmont Medical Research | Winston-Salem, North Carolina 27103 |
| Horizon Research Group, Inc. | Mobile, Alabama 36608 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| International Dermatology Research, Inc. | Miami, Florida |
| Dermatology Consulting Services | High Point, North Carolina |
| Oregon Medical Research Center, PC | Portland, Oregon 97223 |
| Deaconess Clinic Downtown | Evansville, Indiana 47713 |
| Ameriderm Research | Jacksonville, Florida 32216 |
| Radiant Research, Inc. | Greer, South Carolina 29651 |
| Florida Academic Dermatology Center | Miami, Florida 33136 |
| DermResearch, PLLC | Louisville, Kentucky 40217 |
| Radiant Research, Inc. | Chandler, Arizona 85225 |
| Radiant Research, Inc. | Akron, Ohio 44311 |
| Dermatology Specialists, Inc. | Oceanside, California 92056 |
| Expresscare Medical | Los Angeles, California 90045 |
| DMIA | Louisville, Kentucky 40207 |
| Quest Diagnostics | Louisville, Kentucky 40217 |
| Michigan Center for Research Corporation dba Michigan Center for Skin Care Research | Clinton Township, Michigan 48038 |
| Dermatology Associates | Wilmington, North Carolina 28401 |
| New Hanover Medical Research | Wilmington, North Carolina 28401 |
| Triad Dermatology, PA | Winston-Salem, North Carolina 27103 |
| Piedmont Imaging | Winston-Salem, North Carolina 27103 |
| Office of Stephen Miller, MD, PA | San Antonio, Texas 78229 |
| Mountain State Clinical Research | Clarksburg, West Virginia 26301 |
| Center for Dermatology Clinical Research, Inc. | Fremont, California 94538 |
| Longmont Clinic, PC | Longmont, Colorado 80501 |
| Northeast Dermatology Associates | Beverly, Massachusetts 01915 |
| ActivMed Practices and Research, Inc. | Haverhill, Massachusetts 01830 |
| PMG Research of Wilmington LLC | Wilmington, North Carolina 28401 |
| New Hanover Medical Group, PA | Wilmington, North Carolina 28401 |
| Medical Research South, LLC | Charleston, South Carolina 29407 |
| Dermatology & Laser Center of Charleston | Charleston, South Carolina 29414 |
| Office of Marta T. Hampton, MD | Charleston, South Carolina 29407 |
| Office of John Michael Humeniuk, MD | Greer, South Carolina 29650 |
