Actively Recruiting

Phase 3
Age: 19Years +
All Genders
NCT03414502

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Led by University of Nebraska · Updated on 2025-08-08

400

Participants Needed

1

Research Sites

1107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.

CONDITIONS

Official Title

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed rheumatoid arthritis (RA) meeting 4 of 7 American College of Rheumatology criteria
  • Age over 19 years at RA diagnosis
  • Active RA with at least one swollen joint
  • Starting new DMARD medication(s) including abatacept, adalimumab, azathioprine, baricitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, or tofacitinib
  • If on other DMARDs, must have been on a stable dose for at least 6 weeks
  • If on glucocorticoids, must be on a stable dose for at least 2 weeks with less than 10mg prednisone daily or equivalent
  • Able to attend scheduled study visits (enrollment, 8 weeks, and 16 weeks)
  • Hemoglobin greater than 9 g/dL
  • Platelet count greater than 100
  • Creatinine less than 1.6
  • Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 times the upper limit of normal
  • Albumin no more than 1.0 g/dL below the lower limit of normal
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Men and women of childbearing potential who are unwilling to use effective contraception

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

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Research Team

A

Aimee B Schreiner, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

16

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