NCT02308163

A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs

Detailed description

This was a multi-center, randomized, placebo-controlled, double-blind, parallel-group, confirmatory study to evaluate the efficacy and safety of ASP015K alone or in combination with DMARDs in participants with RA who had an inadequate response to DMARDs. Etanercept was also administered as the reference drug in an open-label manner. The study drug was orally administered once daily (QD) after breakfast for 52 weeks. Etanercept was administered subcutaneously QD for 52 weeks. At Week 12, participants in the placebo group were switched to ASP015K. The dose of ASP015K to be started at Week 12 for the placebo group was determined randomly at baseline in advance and switched in a blinded manner. Participants in ASP015K group or placebo groups who had completed the study were eligible for participation in an open-label extension study (015K-CL-RAJ2).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Peficitinib	oral
DRUG	Placebo	oral
BIOLOGICAL	Etanercept	subcutaneous injection

Timeline

• Start date: 2014-08-08
• Primary completion: 2017-01-23
• Completion: 2017-11-22
• First posted: 2014-12-04
• Last updated: 2024-10-28
• Results posted: 2020-03-16

Locations

153 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study