Predicting responses to DMARDs in rheumatoid arthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify predictors of clinical response to disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). It is an open-label, 16-week intervention where participants will receive various DMARD therapies, including methotrexate and others. The study will evaluate clinical and biological parameters, such as rheumatoid factor isotypes and inflammatory markers, to determine their effectiveness in predicting treatment outcomes. The ultimate goal is to improve treatment strategies for RA by understanding which patients are likely to benefit from specific DMARDs.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria

  * Morning stiffness for at least 1 hour for at least 6 weeks
  * Swelling of 3 or more joints for at least 6 weeks
  * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks
  * Symmetric joint swelling
  * Hand x-rays with erosions or bony decalcifications
  * RA nodules
  * Rheumatoid factor (RF) positive
* \>19 yrs old at RA diagnosis
* Active disease with at least 1 swollen joint
* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
* If on other DMARDS, must be on stable dose for ≥ 6 wks
* If on glucocorticoids, must be on stable dose for 2 wks (\< 10mg of Prednisone/day or equivalent)
* Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks)
* Hemoglobin (Hgb) \> 9g/dl
* Platelets \>100
* Creatinine \<1.6
* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit
* Albumin up to 1.0 g/dL below lower limit of normal

EXCLUSION CRITERIA:

* Pregnant or breastfeeding women
* Men and women of child bearing potential unwilling to practice effective method of contraception

Where it's running

• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: James R O'Dell, MD — University of Nebraska
• Study coordinator: Aimee B Schreiner, MS
• Email: aischreiner@unmc.edu
• Phone: 402-559-4873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IV sarilumab for adults with rheumatoid arthritis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.