RA rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) 2) Age of 18 years and older 3) Early RA: disease activity of less than 2 years 4) Active RA, the patient must meet at least one of the following unfavourable prognostic markers: DAS44 score >3.7 OR presence of at least two of the four following features (CRP*35 mg/l OR ESR*50 mm/h; IgM-RF positive; aCCP positive; at least 1 erosion) Patients meeting the first three criteria, but not the criteria for active RA, can participate in the group of patients with a high probability of a mild disease course (low risk group). Patients can also participate in the low risk group, if they score four or five points on the classification criteria (undifferentiated arthritis) ánd a strong suspicion of the treating rheumatologists that the patient will develop RA. Patients meeting all four inclusion criteria, including the active RA criterion, can participate in the group of patients with a potentially severe course of the disease (high risk group).
Exclusion criteria
Exclusion criteria: - Prior treatment DMARDs (except hydroxychloroquine) - Corticosteroid treatment with a supraphysiological dose (>7.5 mg/day) in the four weeks prior to screening - Insulin-dependent Diabetes mellitus - Uncontrollable non-insuline dependent diabetes mellitus - Heart failure NYHA class 3-4 - Uncontrollable hypertension - ALAT/ASAT >3 times normal values - Reduced renal function - Contra-indications for methotrexate, sulphasalazine or prednisolone - Indications of probable tuberculosis - Increased risk of harm due to contraindications to the study drugs - Language problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the difference in disease activity in the two randomisation arms of both groups, measured by the percentage of patients that reach an EULAR good response or a DAS44-score 1.2 points compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are functional ability, remission, radiological progression, and patient reported outcomes. In a subgroup of patients in the high risk group (n=40), PET/CT-scans will be made at baseline and after two weeks. Clinical lab, bone mineral density, body composition, social demographic parameters, and lifestyle factors are tertiary parameters. | — |
Countries
Netherlands
Outcome results
None listed