NCT03414502 · University of Nebraska
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
What this study is about
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.
View original scientific description
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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.
Interventions
DRUG
Methotrexate
Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
DRUG
Abatacept
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Adalimumab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Azathioprine
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Baricitinib
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Certolizumab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Etanercept
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Golimumab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Hydroxychloroquine
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Infliximab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Leflunomide
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Minocycline
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Rituximab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Sarilumab
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Sulfasalazine
Starting dose may be adjusted as needed at investigator's discretion.
DRUG
Tofacitinib
Starting dose may be adjusted as needed at investigator's discretion.
Primary outcome measures
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
Time frame: 16 weeks
The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Omaha, Nebraska
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations