Dynamic Treatment Regiments for Glucocorticoid Tapering (SMART-RA)
Rheumatoid Arthritis
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Disease-modifying anti-rheumatic drug, Oral prednisone, Dose reduction, Tapering
Eligibility Criteria
Inclusion Criteria: Ability to read and speak English to allow for written informed consent and patient-reported outcomes measures. Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Ability to take oral medication and be willing to adhere to the study intervention regimen Diagnosis of rheumatoid arthritis by a medical provider, confirmed by checking medical records. Current use of an RA treatment regimen of both oral prednisone and 1 other Food and Drug Administration-approved disease-modifying antirheumatic drug (DMARD), with no change in this therapy over the past 90 days Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone Patients enrolling in the 150-day taper must be taking 5mg/day oral prednisone Exclusion Criteria: Current or recent (past year) use of systemic glucocorticoid (oral, intravenous, or intramuscular administration) >2 weeks for an indication other than RA, to reduce risk of adverse health outcomes related to worsening of the indicated condition High RA disease activity, defined as a Clinical Disease Activity Index of greater (>) 10, given high likelihood of taper failure in this population due to increased RA activity alone Pre-existing primary or secondary adrenal insufficiency diagnosed by a physician, given high risk of worsening with prednisone taper Treatment with another investigational drug or intervention within 90 days Pregnancy Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
Sites / Locations
- VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
15-day taper prednisone
150-day taper prednisone
This will be for 30 days. Participants will be allocated to the 15-day strategy preferentially until enrollment goals have been met; once completing the 15-day strategy, many participants will also be eligible to complete the 150-day strategy, and may subsequently enroll in it if they wish. Participants that are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.
This will be for 180 days. Participants who are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.