NCT03660059

A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response or intolerance to MTX, as measured by the American College of Rheumatology (ACR) 20 response rate at Week 24. This study will also evaluate the pharmacokinetics and safety of ASP015K as well as efficacy and safety of long-term treatment with ASP015K (52 weeks).

Detailed description

Participants will be randomized in a 1:1:1 ratio to the ASP015K dose-A group, ASP015K dose-B group or placebo group at Week 0.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Peficitinib	Oral
DRUG	Plaebo	Oral
DRUG	Disease-modifying antirheumatic drugs (DMARDs)	As necessary concomitant medications, DMARDs listed below will be administered orally unless specified. For subjects who are inadequate responders to methotrexate (MTX): MTX. For subjects who are intolerant of MTX: either of DMARDs listed; hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod.

Timeline

• Start date: 2018-09-27
• Primary completion: 2021-04-01
• Completion: 2021-11-02
• First posted: 2018-09-06
• Last updated: 2024-10-21

Locations

43 sites across 3 countries: China, South Korea, Taiwan