No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
University of Nebraska · Other
Who this trial is looking for
This trial is looking for people with rheumatoid arthritis to help find out what predicts how well some medications work. Participants will take a DMARD medication for 16 weeks, and their responses will be monitored.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with rheumatoid arthritis.
I have morning stiffness for at least 1 hour for at least 6 weeks.
I have swelling in 3 or more joints for at least 6 weeks.
I have at least 1 swollen joint currently.
I am starting a new DMARD medication.
I am over 19 years old at the time of RA diagnosis.
I am able to attend scheduled study visits.
You may not be able to join if
I am pregnant or breastfeeding.
I am of childbearing potential and I am not willing to use contraception.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
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 interph…
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
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