NCT01881308

Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Diakonhjemmet Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TNF inhibitors
DRUG	Synthetic DMARD(s)
DRUG	Co-medication: Synthetic DMARDs	Synthetic DMARDs given as co-medication for TNF inhibitors as appropriate.

Timeline

• Start date: 2013-06-17
• Primary completion: 2020-01-01
• Completion: 2022-01-01
• First posted: 2013-06-19
• Last updated: 2022-04-26

Locations

10 sites across 1 country: Norway