Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis tofacitinib ACR20 HAQ-DI TNF inhibitor failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
Healthy volunteers: no

Brief summary:
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

Detailed description:

Arms:
arm 1: Tofacitinib 5 mg BID for 6 months arm 2: Tofacitinib 10 mg BID for 6 months arm 3: Placebo for 3 months then tofacitinib 5 mg BID for 3 months arm 4: Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Interventions: intervention 1: Tofacitinib intervention 2: Tofacitinib intervention 3: Placebo intervention 4: Tofacitinib intervention 5: Placebo intervention 6: Tofacitinib
Intervention descriptions: intervention 1: tablets, 5 mg BID x 6 months intervention 2: tablets, 10 mg BID x 6 months intervention 3: tablets, to match tofacitinib 5 mg BID x 3 months intervention 4: tablets, 5 mg BID x 3 months intervention 5: tablets, to match tofacitinib 10 mg BID x 3 months intervention 6: tablets, 10 mg BID x 3 months

Protocol document: