Status:
COMPLETED
Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial
Lead Sponsor:
Espen A. Haavardsholm
Collaborating Sponsors:
The Research Council of Norway
Smerud Medical Research International AS
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known. Ultr...
Eligibility Criteria
Inclusion
- Inclusion criteria (all):
- Male or non-pregnant, non-nursing female
- \> 18 years of age and \< 75 years of age
- Patients classified as having RA (according to new ACR/EULAR criteria)
- Disease duration less than 2 years (defined as time from 1st joint swelling)
- The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
- The patient has taken no prior DMARD
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
- Exclusion Criteria (any):
- Abnormal renal function (serum creatinine \> 142 µmol/L in female and \> 168 µmol/L in male)
- Abnormal liver function, active or recent hepatitis, cirrhosis
- Major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases.
- Leukopenia and/or thrombocytopenia
- Inadequate birth control conception, pregnancy, and/or breastfeeding
- Indications of active tuberculosis
- Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01205854
Start Date
September 1 2010
End Date
April 1 2015
Last Update
April 16 2015
Active Locations (11)
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1
Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology
Bergen, Bergen, Norway, 5021
2
Martina Hansens Hospital AS
Sandvika, Bærum, Norway, 1306
3
Vestre Viken HF, Dept. of Rheumatology
Drammen, Drammen, Norway, 3004
4
Sykehuset Østfold HF, Dept. of Rheumatology
Moss, Fredrikstad, Norway, 1603