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RecruitingPhase 3

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 16-week study looks for signs that predict how well rheumatoid arthritis (RA) drugs will work. It is for people with active RA who are starting a new DMARD, a drug that helps slow joint damage. Everyone will receive DMARD treatment, and the study doctor may change the dose as needed.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have RA that meets at least 4 of 7 standard signs used to diagnose it.
  • Were older than 19 when diagnosed with RA.
  • Have active RA with at least 1 swollen joint.
  • Are starting a new DMARD medicine listed in the study.
  • If taking other DMARDs, have stayed on the same dose for at least 6 weeks.
  • If taking steroids, have stayed on the same dose for at least 2 weeks. The dose must be less than 10 mg of prednisone per day, or an equal dose of another steroid.
  • Can attend visits at the start, week 8, and week 16. The later visits may be up to 2 weeks early or late.
  • Meet blood test limits: hemoglobin above 9 g/dL; platelets above 100; creatinine below 1.6; liver tests AST or ALT no higher than 1.2 times the upper normal limit; and albumin no more than 1.0 g/dL below the lower normal limit.

Who can't join

  • Are pregnant or breastfeeding.
  • Could become pregnant or cause a pregnancy and are unwilling to use effective birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NE