A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

Pfizer

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Drug: CP-690, 550

Drug: CP-690,550

Study type

Interventional

Funder types

Industry

Identifiers

NCT01519089

A3921137

Details and patient eligibility

About

The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.

Enrollment

95 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.
Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
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