Predicting Response to Rheumatoid Arthritis Treatments

This study is looking for people with Rheumatoid Arthritis (RA) to understand how well different medications work. Researchers want to find out what predicts a good response to common RA treatments like Methotrexate, Abatacept, Adalimumab, Azathioprine, and Baricitinib. Currently, it's hard to know which drug will work best for each person. You may be able to join if you have been diagnosed with RA and meet specific criteria, such as having morning stiffness and joint swelling for at least six weeks. The main goal is to see how effective these treatments are after 16 weeks.

Study design
This is an interventional study planning to enroll 400 participants. It will examine how well different disease-modifying antirheumatic drugs (DMARDs) work for rheumatoid arthritis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, efficacy of treatment, is measured at 16 weeks.

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NCT03414502

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting
PHASE3Ages 19+InterventionalTreatment
University of Nebraska
~400 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:MethotrexateAbataceptAdalimumabAzathioprineBaricitinibCertolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
Measured over 16 weeks
Rheumatoid Arthritis
1 sites across 1 states
Nebraska1
  • James R O'Dell, MD · PRINCIPAL_INVESTIGATOR · University of Nebraska

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Pregnant or breastfeeding women
Men and women of child bearing potential unwilling to practice effective method of contraception
  • Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis16 weeks

    The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).