REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design
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
- Disease duration less than five years at inclusion into ARCTIC REWIND, defined as
time from first joint swelling
- 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.