Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial

Espen A. Haavardsholm

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Device: Ultrasonography

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01205854

DIA2010-1

Details and patient eligibility

About

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.

Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients.

This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone.

Enrollment

238 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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