Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

• Status: Recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 16-week, open-label study to identify factors that help predict clinical responses to DMARD therapies for RA (Rheumatoid Arthritis) patients. All patients will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a subject becomes intolerant to a DMARD medication the subject will be withdrawn from the study at the discretion of the investigator. Visits (prior to week 16) where withdrawal is determined to be necessary will be considered end of study. End of study data (week 16) as well as study serum will be collected. (Serum only collected on those subjects who have consented to the addendum Serum and DNA of this study). A portion of the blood collected at baseline, week 8 and week 16 with the addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. The radicals have been shown to be associated with inflammation and may correlate with the progression of RA. If this is true, then treatment with RA should decrease the levels of these radicals signaling response to treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Treatments: Abatacept; Adalimumab; Azathioprine; Certolizumab Pegol; Etanercept; Golimumab; Hydroxychloroquine; Infliximab; Leflunomide; Methotrexate; Minocycline; Rituximab; Sulfasalazine; Tofacitinib

Criteria

INCLUSION CRITERIA:

• Diag. with RA with 4 of 7 ACR criteria: 1) Morning stiffness for at least 1 hr. and at least 6 wks 2) Swelling of 3 or more joints for at least 6 wks. 3) Swelling of wrist, MCP, or proximal interphalangeal joints for 6 or more wks 4) Symmetric joint swelling. 5) Hand x-rays with erosions or bony decalcifications. 6) RA nodules 7) RF positive

• >19 yrs old at time of diagnosis of RA

• Current active disease with at least1 swollen joint

• Starting new DMARD medication(s) please circle: 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 per day or equivalent)

• Able to adhere to study visit schedule: enrollment, 8 wks & 16 wks (+/- 2 wks)

• Hgb > 9g/dl

• WBC > 3.5

• Neutrophils > 1.0

• Platelets >100

• Creatinine <1.6

• AST or ALT not over 1.2 x upper limit

• Albumin: up to 1.0 g/dL less than lower limit of normal

EXCLUSION CRITERIA:

• Pregnant or breastfeeding women

• Men and women of child bearing potential not willing to practice successful method of contraception