drugset / Trial / NCT02996500
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |