Biomarkers of Treatment Response in Rheumatoid Arthritis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001238
Sponsor Protocol Number: 17-001238
About this study
Objective: Identify a microbial biomarker signature that is predictive of treatment response in patients with rheumatoid arthritis (RA).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Eligibility Criteria: Patients with RA will be included if they meet the following criteria:
- Adult patients ≥ 18 years of age.
- Fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis (RA).
- Fulfillment of the definition of inadequate response to previous DMARD therapy, according to the following criteria:
- Previous treatment for at least 3 months with at least 1 of the following conventional synthetic DMARDs: methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine.
- Previous treatment (any duration) with no greater than 3 biologic or targeted synthetic DMARDs (see list below) is acceptable.
- Moderate-to-high disease activity as defined by the Disease Activity Score 28, 4-variable version, using the C-reactive protein (DAS28-CRP) of ≥3.2.
- Starting an eligible biologic or targeted synthetic DMARD, including one of the following medications:
- TNF inhibitors (adalimumab, certolizumab, etanercept, golimumab, or infliximab)
- Abatacept (Orencia; IV or SC)
- Tocilizumab (Actemra; IV or SC)
- Rituximab (Rituxan; IV)
- Tofacitinib (Xeljanz)
- Prednisone therapy is acceptable if at a dose of ≤10 mg/day for the prior 2 weeks.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Davis, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available