COBRA treat-to-target trial - COBRA treat-to-target trial

Vrije Universiteit Medisch Centrum0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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).

•- 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

发起方