Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting now · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified. This study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.

Key facts

Study ID: NCT03414502
Run by: University of Nebraska
People needed: 400
Starts: 2007-12-10
Expected to finish: 2029-03-01
Last updated by the study team: 2026-06-17

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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