drugset / Trial / NCT02996500

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

NCT02996500

Phase 2 Completed 269 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tofacitinib Small molecule 5 mg Oral
Subject ZIMLOVISERTIB Small molecule 20 mg Oral
Subject ZIMLOVISERTIB Small molecule 60 mg Oral
Subject ZIMLOVISERTIB Small molecule 200 mg Oral
Subject ZIMLOVISERTIB Small molecule 400 mg Oral

Indications