Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant or breastfeeding women

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

Trial design

Treatments tested in this trial

  • Methotrexate
  • Abatacept
  • Adalimumab
  • Azathioprine
  • Baricitinib
  • Certolizumab
  • Etanercept
  • Golimumab
  • Hydroxychloroquine
  • Infliximab
  • Leflunomide
  • Minocycline
  • Rituximab
  • Sarilumab
  • Sulfasalazine
  • Tofacitinib

Treatment groups

400 Participants
are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Sponsors and collaborators