Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

Timeline

Start

2016-09-14

Primary completion

2018-06-25

Completion

2018-06-25

Outcome

Missed primary endpoint

registry analysis (superiority test); JTE-051 50 mg vs Placebo; p = 0.842; Fisher Exact NCT02919475 ↗

registry analysis (superiority test); JTE-051 100 mg vs Placebo; p = 0.841; Fisher Exact NCT02919475 ↗

registry analysis (superiority test); JTE-051 150 mg vs Placebo; p = 0.842; Fisher Exact NCT02919475 ↗

registry analysis (superiority test); JTE-051 200 mg vs Placebo; p >0.999; Fisher Exact NCT02919475 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JTE-051	Unknown	—	Oral

Indications