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Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

NCT01881308 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-04-26

No results posted yet for this study

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

Interventions

DRUG

TNF inhibitors

DRUG

Synthetic DMARD(s)

DRUG

Co-medication: Synthetic DMARDs

Synthetic DMARDs given as co-medication for TNF inhibitors as appropriate.

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Espen A. Haavardsholm, MD PhD · Diakonhjemmet Hospital

  • Tore K Kvien, MD PhD · Diakonhjemmet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-17
Primary Completion
2020-01-31
Completion
2022-01-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881308 on ClinicalTrials.gov