A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2b Study of ASP015K -Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Subjects -|
- Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percentage of Subjects achieving ACR 50 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percentage of Subjects achieving ACR 70 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
- Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests [ Time Frame: During 12-week treatment period and 4-week follow-up period ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: ASP015K lowest dose||
|Experimental: ASP015K low dose||
|Experimental: ASP015K medium dose||
|Experimental: ASP015K high dose||
|Placebo Comparator: Placebo||
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.
|Contact: Clinical Development Administration Dept.||email@example.com|
|Study Director:||Medical Director||Astellas Pharma Inc|