A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy
Phase 2
- Conditions
- Rheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON30206
- Lead Sponsor
- Serono
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
The trial will enrol adult subjects of either sex who have at least a one-year history of rheumatoid factor (RF)-positive rheumatoid arthritis satisfying American College of Rheumatology criteria and who have failed treatment with at least one TNF alpha antagonist ( etanercept, infliximab or adalimumab).
Exclusion Criteria
Subjects who have received belimumab or abatacept will be excluded, as will those who have received rituximab, etanercept, infliximab, adalimumab or investigational treatments or procedures within specified periods before studyday 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of subjects achieving an ACR20 response at Week 26</p><br>
- Secondary Outcome Measures
Name Time Method