Status:
COMPLETED
Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis
Lead Sponsor:
Diakonhjemmet Hospital
Collaborating Sponsors:
The Research Council of Norway
South-Eastern Norway Regional Health Authority
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01881308
Start Date
June 17 2013
End Date
January 1 2022
Last Update
April 26 2022
Active Locations (10)
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1
Department of Rheumatology, Helse Møre og Romsdal HF
Ålesund, Norway, 6026
2
Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
Bergen, Norway, 5021
3
Department of Rheumatology, Drammen Hospital, Vestre Viken HF
Drammen, Norway, 3004
4
Department of Rheumatology, Sykehuset Østfold HF
Fredrikstad, Norway, 1603