COBRA treat-to-target trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 190

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

- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the difference in disease activity in the two<br /><br>randomisation arms of both groups, measured by the percentage of patients that<br /><br>reach an EULAR good response or a DAS44-score <1.6 at 26 weeks. EULAR good<br /><br>response is reached when the DAS44-score is *2.4 and has improved >1.2 points<br /><br>compared to baseline. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are functional ability, remission, radiological<br /><br>progression, and patient reported outcomes. In a subgroup of patients in the<br /><br>high risk group (n=40), PET/CT-scans will be made at baseline and after two<br /><br>weeks.<br /><br><br /><br>Clinical lab, bone mineral density, body composition, social demographic<br /><br>parameters, and lifestyle factors are tertiary parameters.</p><br>