Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Status:	Completed
Conditions:	Arthritis, Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery, Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2014
End Date:	December 2015

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

This is a 12 month study investigating the effectiveness and safety of tofactinib in
treating the signs and symptoms, improving physical function and preserving bone structure
in patients with active psoriatic arthritis and had inadequate response to a traditional,
non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.

Inclusion Criteria:

- Males or females, aged >= 18 years at time of consent.

- Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

- Meet the Classification Criteria of PsA (CASPAR) at time of screening

- Must not have been adequately treated with a a traditional non-biologic disease
modifying anti-rheumatic drug (DMARD).

- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and
required

- Must not have taken a biologic Tumour Necrosis Factor Inhibitor

- Must have 3 or more swollen joints AND 3 or more tender joints

- Must have active psoriasis skin lesions

Exclusion Criteria:

- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the
exception of nail psoriasis which is allowed

- Pregnant or breast feeding, females of child-bearing potential not using highly
effective contraception

- New York Heart Association Class III and IV congestive heart failure

- History of hypersensitivity or infusion reaction to biologic agents

- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

We found this trial at

sites

Physician Research Collaboration

Lincoln, Nebraska 68512

721

from 43215

Lincoln, NE