Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease

NCT02742337 | Unknown

• 1 other identifier: AE010831
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Keywords

Epigenetic

Outcome Measures

Primary Outcomes (1)

• Counts of patients with epigenetic signatures.

  The identification of a statistically significant number of RA patients having a consistent epigenetic signature

  1 day

Study Arms (2)

Test

Newly diagnosed female patients with rheumatoid arthritis who have not previously used a disease modifying anti-rheumatic drug.

Control

Female patients not having a diagnosis of rheumatoid arthritis and who have not previously used a disease modifying anti-rheumatic drug.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is at-risk patients for chronic auto-immune and rheumatic disease.

You may qualify if:

• 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+
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthritis Northwest PLLC: lead
• Epigenesys LLC: collaborator

Study Sites (1)

Arthritis Northwest

Spokane, Washington, 99208, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens Collected: 1. Blood: Monocytes 2. Mucosal Swab: Buccal cells

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Gary L Craig, MD

CONTACT

5098386500; gcraig@arthritisnw.com

Keith Knapp, PhD

CONTACT

5098386500; kknapp@arthritisnw.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)