What this study is
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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.
What's being tested
- Methotrexate
Intervention · DRUG
Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
- Abatacept
Intervention · DRUG
- Adalimumab
Intervention · DRUG
- Azathioprine
Intervention · DRUG
- Baricitinib
Intervention · DRUG
- Certolizumab
Intervention · DRUG
- Etanercept
Intervention · DRUG
- Golimumab
Intervention · DRUG
- Hydroxychloroquine
Intervention · DRUG
- Infliximab
Intervention · DRUG
- Leflunomide
Intervention · DRUG
- Minocycline
Intervention · DRUG
- Rituximab
Intervention · DRUG
- Sarilumab
Intervention · DRUG
- Sulfasalazine
Intervention · DRUG
- Tofacitinib
Intervention · DRUG
All of Abatacept, Adalimumab, Azathioprine, Baricitinib, Certolizumab, Etanercept, Golimumab, Hydroxychloroquine, Infliximab, Leflunomide, Minocycline, Rituximab, Sarilumab, Sulfasalazine, Tofacitinib
Starting dose may be adjusted as needed at investigator's discretion.
Study details
- Official title
- Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
- Sponsor
- University of Nebraska
- Conditions
- Rheumatoid Arthritis
- Enrolling
- 400 people
- Starts
- 2007-12-10
- Est. completion
- 2029-03
- Design
- Open-label, non-randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Pregnant or breastfeeding women
- Men and women of child bearing potential unwilling to practice effective method of contraception
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
- Aimee B Schreiner, MS · Contact402-559-7288aischreiner@unmc.edu
- Bridget E Kramer, RN · Contact402-559-7288bridget.kramer@unmc.edu
- James R O'Dell, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Nebraska
Study ID 0439-23-FB
Principal investigator
James R O'Dell, MD
University of Nebraska
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.