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Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Sponsor: University of Nebraska
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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.
Official title: Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2007-12-10
Completion Date
2029-03
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
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.
Locations (1)
University of Nebraska Medical Center
Omaha, Nebraska, United States