RecruitingPhase 3NCT03414502

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

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


Sponsor

University of Nebraska

Enrollment

400 participants

Start Date

Dec 10, 2007

Study Type

INTERVENTIONAL

Conditions

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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to find biological markers in the blood and tissue of rheumatoid arthritis patients that can predict who will respond well to specific medications (called DMARDs), so doctors can choose the right treatment more quickly. **You may be eligible if...** - You have a confirmed diagnosis of rheumatoid arthritis (RA) meeting standard medical criteria - You are older than 19 at the time of your RA diagnosis - Your arthritis is currently active (at least one swollen joint) - You are starting a new DMARD medication such as abatacept, adalimumab, etanercept, infliximab, methotrexate, or rituximab **You may NOT be eligible if...** - You are already on the medication you are about to start (i.e., you are not a new starter) - You have serious other conditions that would affect the results - You are unable to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.

DRUGAbatacept

Starting dose may be adjusted as needed at investigator's discretion.

DRUGAdalimumab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGAzathioprine

Starting dose may be adjusted as needed at investigator's discretion.

DRUGBaricitinib

Starting dose may be adjusted as needed at investigator's discretion.

DRUGCertolizumab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGEtanercept

Starting dose may be adjusted as needed at investigator's discretion.

DRUGGolimumab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGHydroxychloroquine

Starting dose may be adjusted as needed at investigator's discretion.

DRUGInfliximab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGLeflunomide

Starting dose may be adjusted as needed at investigator's discretion.

DRUGMinocycline

Starting dose may be adjusted as needed at investigator's discretion.

DRUGRituximab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGSarilumab

Starting dose may be adjusted as needed at investigator's discretion.

DRUGSulfasalazine

Starting dose may be adjusted as needed at investigator's discretion.

DRUGTofacitinib

Starting dose may be adjusted as needed at investigator's discretion.


Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT03414502


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