Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Summary

This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered orally BID for 12 weeks in a blinded fashion.

Timeline

Start

2016-11-10

Primary completion

2018-08-15

Completion

2018-08-15

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs PF-06650833 20 mg; p = 0.0050; Mean Difference (Net) -7.83 (95% CI -13.73 to -1.97); ANCOVA NCT02996500 ↗

Drugs

Indications