Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis (ARCTIC REWIND)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- Male or non-pregnant, non-nursing female
- >18 years of age and <80 years of age
- Patient in the TNF-inhibitor group: Any disease duration. Patient in the synthetic DMARD group: RA diagnosis after 01.01.2010.
- Sustained remission for ≥12 months according to DAS or Disease Activity Score based on 28 joints (DAS28), with documented remission status at a minimum of 2 consecutive visits during the last 18 months OR participation in the first ARCTIC trial
- DAS <1.6 and no swollen joints at inclusion OR participation in the first ARCTIC trial
- Unchanged treatment with TNF inhibitors and/or synthetic DMARDs during the previous 12 months, with a stable or reduced dose of glucocorticosteroids OR participation in the first ARCTIC trial
- Subject capable of understanding and signing an informed consent form
- Provision of written informed consent
Exclusion Criteria:
- Abnormal renal function, defined as serum creatinine >142 μmol/L in female and >168 μmol/L in male, or a glomerular filtration rate (GFR) <40 mL/min/1.73 m2
- Abnormal liver function (defined as aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) >3x upper normal limit), active or recent hepatitis, cirrhosis
- Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases
- Leukopenia and/or thrombocytopenia
- Inadequate birth control, pregnancy, and/or breastfeeding
- Indications of active tuberculosis
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
Sites / Locations
- Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
- Department of Rheumatology, Drammen Hospital, Vestre Viken HF
- Department of Rheumatology, Sykehuset Østfold HF
- Department of Rheumatology, Sørlandet Sykehus HF
- Revmatismesykehuset AS
- Helgelandssykehuset, Mo i Rana
- Department of Rheumatology, Diakonhjemmet Hospital
- Martina Hansens Hospital AS
- Universitetssykehuset Nord-Norge HF
- Department of Rheumatology, Helse Møre og Romsdal HF
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Active Comparator
Experimental
Other
Stable dose TNF inhibitor
Stepdown and withdrawal of TNF inhibitor
Stable dose synthetic DMARD
Synthetic DMARD dose reduction
ARCTIC follow-up
Stable dose TNF inhibitor. Any co-medication with synthetic DMARDs kept stable.
Half-dose of TNF inhibitor for the first four months, thereafter withdrawal of TNF inhibitor. Any co-medication with synthetic DMARDs kept stable.
Stable dose of synthetic DMARDs, either monotherapy or combination therapy.
Half-dose synthetic DMARDs (monotherapy or combination therapy) for the first 12 months of the study. Patients classified as non-failures are re-randomized at 12 months to either continue half-dose synthetic DMARD(s) or withdraw all DMARD(s).
Patients are treated according to the ARCTIC treatment schedule based on disease activity.