Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis, Rheumatology |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | September 2016 |
| Contact: | Gary L Craig, MD |
| Email: | gcraig@arthritisnw.com |
| Phone: | 5098386500 |
• 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.
(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.
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.
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.
Test patient 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
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