Recruiting
Phase 3

DMARDs

Sponsor:

University of Nebraska

Code:

NCT03414502

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Methotrexate

Abatacept

Adalimumab

Azathioprine

Baricitinib

Study Details

Brief summary:

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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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

Rheumatoid Arthritis

Study ID

NCT03414502

Start date

Dec 10, 2007

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Methotrexate Therapy

Participants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment.

active comparator: Abatacept Therapy

Participants will receive abatacept therapy for rheumatoid arthritis (RA) treatment.

active comparator: Adalimumab Therapy

Participants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Azathioprine Therapy

Participants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment.

active comparator: Barcitinib Therapy

Participants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment.

active comparator: Certolizumab Therapy

Participants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Etanercept Therapy

Participants will receive etanercept therapy for rheumatoid arthritis (RA) treatment.

active comparator: Golimumab Therapy

Participants will receive golimumab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Hydroxycholoroquine Therapy

Participants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment.

active comparator: Infliximab Therapy

Participants will receive infliximab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Leflunomide Therapy

Participants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment.

active comparator: Minocycline Therapy

Participants will receive minocycline therapy for rheumatoid arthritis (RA) treatment.

active comparator: Rituximab Therapy

Participants will receive rituximab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Sarilumab Therapy

Participants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment.

active comparator: Sulfasalazine Therapy

Participants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment.

active comparator: Tofacitinib Therapy

Participants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment.

Interventions

Methotrexate

Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.

Abatacept

Starting dose may be adjusted as needed at investigator's discretion.

Adalimumab

Starting dose may be adjusted as needed at investigator's discretion.

Azathioprine

Starting dose may be adjusted as needed at investigator's discretion.

Baricitinib

Starting dose may be adjusted as needed at investigator's discretion.

Certolizumab

Starting dose may be adjusted as needed at investigator's discretion.

Etanercept

Starting dose may be adjusted as needed at investigator's discretion.

Golimumab

Starting dose may be adjusted as needed at investigator's discretion.

Hydroxychloroquine

Starting dose may be adjusted as needed at investigator's discretion.

Infliximab

Starting dose may be adjusted as needed at investigator's discretion.

Leflunomide

Starting dose may be adjusted as needed at investigator's discretion.

Minocycline

Starting dose may be adjusted as needed at investigator's discretion.

Rituximab

Starting dose may be adjusted as needed at investigator's discretion.

Sarilumab

Starting dose may be adjusted as needed at investigator's discretion.

Sulfasalazine

Starting dose may be adjusted as needed at investigator's discretion.

Tofacitinib

Starting dose may be adjusted as needed at investigator's discretion.

Primary outcome measure

  • Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Aimee B Schreiner, MS

402-559-4873aischreiner@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Aimee B Schreiner, MS

402-559-7288aischreiner@unmc.edu

Bridget E Kramer, RN

402-559-7288bridget.kramer@unmc.edu

Principal Investigator:

James R O'Dell, MD

More Information

Sponsor

University of Nebraska

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Methotrexate
  • DMARD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-06-17.