NCT03414502RecruitingPhase 3
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 2 Jan 2014
- Start date
- 10 Dec 2007
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- University of Nebraska
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03414502
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 10 Dec 2007 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnant or breastfeeding women
- Men and women of child bearing potential unwilling to practice effective method of contraception
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.