Predicting responses to DMARDs in rheumatoid arthritis treatment
Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
This study is testing if certain blood markers can help predict how well different arthritis medications will work for people with rheumatoid arthritis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | adalimumab, certolizumab, golimumab, infliximab, rituximab, sarilumab, barcitinib, tofacitinib, methotrexate, Prednisone |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT03414502 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with rheumatoid arthritis who are starting new DMARD medications and have active disease.
Not a fit: Patients who do not have rheumatoid arthritis or those who are not starting new DMARD therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for patients with rheumatoid arthritis.
How similar studies have performed: Other studies have explored predictors of response to DMARDs, but this specific approach focusing on a range of clinical and biological parameters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Omaha, Nebraska
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.