Trial Information
A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-Term Safety, Tolerability And Efficacy Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
Inclusion Criteria:
- Are 20 years or older and considered to be candidates for systemic or phototherapy.
[Moderate to Severe Plaque Psoriasis]
- Diagnosed for at least 12 months.
- Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis
covering at least 10% of body surface area (BSA).
[Psoriatic Arthritis]
- Diagnosed for at least 6 months.
- Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints) and
active plaque psoriasis with at least 2 cm in diameter.
Exclusion Criteria:
- Non-plaque or drug induced forms of psoriasis
- Cannot discontinue current oral, injectable or topical therapy for
psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
- 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:
Incidence of adverse events, clinical laboratory abnormalities, vital sign abnormalities and electrocardiogram (ECG) abnormalities
Outcome Time Frame:
Up to Week 52
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
A3921137
NCT ID:
NCT01519089
Start Date:
March 2012
Completion Date:
January 2014
Related Keywords:
- Psoriasis
- Arthritis, Psoriatic
- chronic
- severe
- moderate
- treatment
- safety
- efficacy
- CP-690
- 550
- Plaque psoriasis
- Psoriasis Vulgaris
- Psoriatic Arthritis
- Arthritis
- Arthritis, Psoriatic
- Psoriasis