A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD
Phase 1
- Conditions
- Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment.MedDRA version: 6.1Level: PTClassification code 10039073
- Registration Number
- EUCTR2004-004995-35-IT
- Lead Sponsor
- COMBINATORX, INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie CRx-139's efficacy in RA patients partially responsive to DMARDs?
How does CRx-139 plus DMARD therapy compare to steroid plus DMARD therapy in ACR-20 response for EUCTR2004-004995-35-IT?
Which biomarkers predict ACR-20 response to CRx-139 in RA patients with partial DMARD responsiveness?
What are the safety profiles of CRx-139 and steroids when combined with DMARDs in RA patients?
What are the therapeutic advantages of Combinatorx's CRx-139 over other DMARD combinations or biologics in RA treatment?