Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis
Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs
(DMARDs) dose reduction in patients with rheumatoid arthritis (RA).
Remission is the treatment target in RA, but knowledge about the best way to treat RA
patients who achieve sustained remission is limited. DMARDs have potential serious adverse
events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are
to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients
in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs
in this patient group, and to study cost-effectiveness of different treatment options in RA
remission.
ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV,
non-inferiority strategy study. Patients with less than five years of disease duration and
stable remission for at least 12 months are randomized to either continued stable treatment
or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and
synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome
measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary
endpoint of the study is the proportion of patients who are non-failures (have not
experienced a flare) at 12 months. Secondary endpoints include composite disease activity
scores and remission criteria, joint damage and inflammation assessed by various imaging
modalities, work participation, health care resource use and health related quality of life.
Phase:
Phase 4
Details
Lead Sponsor:
Diakonhjemmet Hospital
Collaborators:
South-Eastern Norway Regional Health Authority The Research Council of Norway