Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs

Phase 1

• Conditions: Rheumatoid arthritis (RA); MedDRA version: 15.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005275-14-NO
• Lead Sponsor: Diakonhjemmet Hospital AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-04
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

a)Rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria (48), Appendix 2.
b)Male or non-pregnant, non-nursing female
c)>18 years of age and < 80 years of age
d)Disease duration less than five years at inclusion into ARCTIC REWIND, defined as time from first joint swelling
e)Sustained remission for = 12 months according to DAS or DAS28, with documented remission status at a minimum of 2 consecutive visits during the last 18 months OR participation in the first ARCTIC trial
f)DAS < 1.6 and no swollen joints at inclusion OR participation in the first ARCTIC trial
g)Unchanged treatment with TNFi and/or synthetic DMARDs during the previous 12 months, with a stable or reduced dose of glucocorticosteroids OR participation in the first ARCTIC trial
h)Subject is capable of understanding and signing an informed consent form
i)Provision of written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

a)Abnormal renal function, defined as serum creatinine > 142 µmol/L in female and > 168 µmol/L in male, or a GFR < 40 mL/min/1.73 m2
b)Abnormal liver function (defined as ASAT/ALAT > 3 x upper normal limit), active or recent hepatitis, cirrhosis
c)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
d)Leukopenia and/or thrombocytopenia
e)Inadequate birth control, pregnancy, and/or breastfeeding
f)Indications of active TB
g)Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified