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 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
18 Years
N/A
Both
Psoriasis
Trial Information
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 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Inclusion Criteria:
- Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
- Have plaque-type psoriasis covering at least 10% of total body surface area
- Considered by dermatologist investigator to be a candidate for systemic therapy or
phototherapy of psoriasis
Exclusion Criteria:
- Non-plaque or drug induced forms of psoriasis
- Cannot discontinue current systemic and/or topical therapies for the treatment of
psoriasis
- Cannot discontinue phototherapy
- 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:
Physician's Global Assessment (PGA) response ie, the proportion of subjects achieving a PGA of "clear" or "almost clear", at Week 12
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
European Union: European Medicines Agency
Study ID:
A3921080
NCT ID:
NCT01241591
Start Date:
November 2010
Completion Date:
January 2013
Related Keywords:
- Psoriasis
- CP- 690
- 550
- Etanercept
- Moderate
- Severe
- Chronic
- Plaque
- Psoriasis
- Efficacy
- Safety
- Psoriasis
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