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Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

NCT03414502 · University of Nebraska
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Official title
Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
About this study
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. Investigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria), including rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1. The purpose of the study is to prospectively gather information on participants with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specifically, to evaluate the efficacy of DMARD therapy as defined by attaining American College of Rheumatology 50 (ACR50) response after 16 weeks of therapy and to identify predictors of DMARD response, such as genetic factors, serological factors or co-morbid conditions. A maximum of 400 rheumatoid arthritis (RA) participants will be enrolled in this 16-week, open-label study. Adult males and females will be enrolled, but RA is approximately three times more common in females.
Eligibility criteria
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 * 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 EXCLUSION CRITERIA: * Pregnant or breastfeeding women * Men and women of child bearing potential unwilling to practice effective method of contraception
Study design
Enrollment target: 400 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2007-12-10
Estimated completion: 2029-03
Last updated: 2025-08-08
Interventions
Drug: MethotrexateDrug: AbataceptDrug: AdalimumabDrug: AzathioprineDrug: BaricitinibDrug: CertolizumabDrug: EtanerceptDrug: GolimumabDrug: HydroxychloroquineDrug: InfliximabDrug: LeflunomideDrug: MinocyclineDrug: RituximabDrug: SarilumabDrug: SulfasalazineDrug: Tofacitinib
Primary outcomes
  • Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis (16 weeks)
Sponsor
University of Nebraska · other
Contacts & investigators
ContactAimee B Schreiner, MS · contact · aischreiner@unmc.edu · 402-559-4873
InvestigatorJames R O'Dell, MD · principal_investigator, University of Nebraska
All locations (1)
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response · TrialPath