Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease

April 14, 2016 updated by: Arthritis Northwest PLLC
• 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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Arthritis Northwest
        • Contact:
        • Sub-Investigator:
          • Keith D Knapp, Ph.D.
        • Principal Investigator:
          • Gary Craig, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthritis Northwest PLLC

Collaborators

Epigenesys LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AE010831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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