Conditions: Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis Joint Structure Magnetic Resonance Imaging Janus Kinase (JAK) Inhibitor Tasocitinib Tofacitinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Tasocitinib plus Methotrexate intervention 2: Tofacitinib plus placebo methotrexate intervention 3: Placebo tofacitinib plus Methotrexate
Intervention descriptions: intervention 1: Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months intervention 2: Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1. intervention 3: Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib

Protocol document: