Recruiting

Epigenetic Biomarkers

Sponsor:

Arthritis Northwest PLLC

Code:

NCT02742337

Conditions

Arthritis, Rheumatoid

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT02742337

Start date

Oct, 2015

Status verified date

Apr, 2016

Completion date

Sep, 2016

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Counts of patients with epigenetic signatures. [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Gary L Craig, MD

5098386500gcraig@arthritisnw.com

Keith Knapp, PhD

5098386500kknapp@arthritisnw.com

Locations

Arthritis Northwest

Recruiting

Spokane, Washington, United States, 99208

Contacts

Keith D Knapp, Ph.D.

509-838-6500kknapp@arthritisnw.com

Principal Investigator:

Gary Craig, M.D.

More Information

Sponsor

Arthritis Northwest PLLC

Last update posted

Apr 19, 2016

Last verified

Apr, 2016

Keywords

  • Epigenetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arthritis Northwest PLLC on 2016-04-19.