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

Phase 4
18 Years
80 Years
Open (Enrolling)
Rheumatoid Arthritis

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Trial Information

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

- 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,

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who are non-failures (have not experienced a flare)

Outcome Description:

Flare is defined as composite measure: (1) An increase in disease activity score (DAS) to >1.6 AND (2) a change in DAS of at least 0.6 AND (3) > 1 swollen joint. If a patient does not fulfill this formal definition, but experiences a clinically significant flare according to the investigator and patient, this is treated as a flare.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Espen A. Haavardsholm, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Diakonhjemmet Hospital


Norway: Regional Ethics Commitee

Study ID:




Start Date:

June 2013

Completion Date:

October 2018

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid