drugset / Trial / NCT04413617

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

NCT04413617 ↗

Phase 2 Completed 460 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

Timeline

Start
2020-07-29
Primary completion
2022-02-07
Completion
2022-02-07

Outcome

Mixed primary results

registry p = 0.0158; Mean Difference (Final Values) -0.35 (90% CI -0.62 to -0.08) NCT04413617 ↗

registry p = 0.3933; Mean Difference (Final Values) -0.04 (90% CI -0.32 to 0.23) NCT04413617 ↗

registry A negative value in change from BL indicates an improvement. NCT04413617 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ritlecitinib Small molecule 100 mg —
Subject Tofacitinib Small molecule 11 mg —
Subject ZIMLOVISERTIB Small molecule 400 mg —

Indications