NCT02742337

Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Arthritis Northwest PLLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

• Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.

Detailed description

Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.

Conditions

• Arthritis, Rheumatoid

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-04-19
• Last updated: 2016-04-19

Locations

1 site across 1 country: United States