Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT01186744
Start Date
September 1 2010
End Date
January 1 2013
Last Update
December 26 2018
Active Locations (87)
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1
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
2
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
3
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
4
Associates In Research, Inc.
Fresno, California, United States, 93720