Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02742337

Enrollment

Registered

2016-04-19

Start date

2015-10-31

Completion date

2016-09-30

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Epigenetic

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactGary L Craig, MD

gcraig@arthritisnw.com5098386500

Backup ContactKeith Knapp, PhD

kknapp@arthritisnw.com5098386500

Outcome results