Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Launched by UNIVERSITY OF NEBRASKA · Jan 22, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how well certain medications called disease-modifying antirheumatic drugs (DMARDs) work for people with rheumatoid arthritis (RA). The goal is to find out what factors can help predict which patients will respond best to these treatments over a period of 16 weeks. If you join the study, you will start on a DMARD and your doctor may adjust your dose if needed. The trial involves visits at the beginning, after 8 weeks, and again at 16 weeks, where researchers will collect information about your health and some blood samples to help understand how the treatment is working.

To be eligible for this study, you should be at least 19 years old and have a diagnosis of rheumatoid arthritis that meets certain criteria, such as having morning stiffness or swelling in multiple joints. You should also be starting a new DMARD medication or have been on a stable dose of another DMARD for at least 6 weeks. It’s important to know that pregnant or breastfeeding women cannot participate, and women and men of childbearing age must agree to use contraception during the study. Overall, this trial aims to improve our understanding of RA treatment and help identify how to better manage this condition for patients.

Gender

ALL

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