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NotablePrimary completion date: Mar 2027 to Mar 2028Completion date: Mar 2028 to Mar 2029v15Show 1 more changeShow less
Completion date: Mar 2028 to Mar 2029
NotablePrimary endpoints: 2 to 1Eligibility criteria shortened, about 15 words · Secondary endpoints revised (3) · Study description shortened, about 70 wordsv14Show 3 more changesShow less
NotablePrimary completion date: Mar 2026 to Mar 2027v13
NotablePrimary endpoints revised (2)Eligibility criteria expanded, about 6 words · Secondary endpoints revised (3) · Study description shortened, about 29 wordsv12Show 3 more changesShow less
NotablePrimary completion date: Mar 2025 to Mar 2026Completion date: Mar 2027 to Mar 2028v11Show 1 more changeShow less
Completion date: Mar 2027 to Mar 2028
MinorSite contact updatedv10
MinorRe-verified, no change to tracked fieldsv9
NotableStart date: Aug 2007 to Dec 10, 2007v8
MinorSite contact updatedv7
Minor3 versionsRe-verified since Nov 4, 2022, no change to tracked fieldsv4-v6
NotablePrimary completion date: Aug 2019 to Mar 2025Primary endpoints: 1 to 2 · Enrollment target: 300 to 400 · Completion date: Aug 2019 to Mar 2027 · 7 morev3Show 10 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.