NCT01649999

A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.

Detailed description

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching placebo in subjects with moderate to severe RA, with or without prior antirheumatic medication, and regardless of responsiveness to the medication. The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a 4-week Follow-up period. Subjects in each treatment group will take ASP015K or matching placebo orally, once daily, after breakfast for 12 weeks after the screening period.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	peficitinib	oral
DRUG	Placebo	oral

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-07-20
• Completion: 2013-07-20
• First posted: 2012-07-25
• Last updated: 2024-10-21

Locations

7 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study