Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis radiographic changes active comparator tofacitinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 422
Healthy volunteers: no

Brief summary:
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Tofacitinib 5 mg BID intervention 2: Tofacitinib 10 mg BID intervention 3: Adalimumab intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months intervention 2: Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months intervention 3: Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months intervention 4: Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months intervention 5: Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Protocol document: