Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT01211678
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of the ability of an 8-gene biomarker set to differentiate between participants who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy 14 weeks
- Secondary Outcome Measures
Name Time Method Comparison of the behavior of the 8-gene marker set in participants who are anti-TNF naïve versus those who begin their second anti-TNF treatment 14 weeks Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses. 14 weeks Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy. 14 weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸Franklin, Wisconsin, United States