Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT02742337
• Lead Sponsor: Arthritis Northwest PLLC

Brief 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.

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Must fulfill the 2010 ACR rheumatoid arthritis classification criteria.
• Must have at least moderate disease activity (CDAI) for most recent disease activity score
• Any history of NSAID or corticosteroid use is acceptable
• Weight at time of blood draw must be greater than 110 lbs.
• Must be RF+ or CCP+

Control patient Inclusion Criteria:

• Female (age: 18 - 80)
• Must not fulfill the 2010 ACR rheumatoid arthritis classification criteria.
• Weight at time of blood draw must be greater than 110 lbs.
• Age will be within 5 years of a test patient.

Exclusion Criteria

• Male
• Age 17 or less
• History of Disease Modifying Anti-Rheumatic Drugs (DMARDs), or biologic DMARDs.
• History of malignancy, except non-melanoma skin cancer
• Previous treatment for malignancy with chemotherapy agents
• Patient reported history of HIV, HepB, HepC, or TB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Counts of patients with epigenetic signatures.	1 day	The identification of a statistically significant number of RA patients having a consistent epigenetic signature

Trial Locations

Locations (1)

Arthritis Northwest; 🇺🇸 Spokane, Washington, United States