A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA

niversity Hospitals Leuven0 个研究点目标入组 400 人开始时间: 2009年2月12日最近更新: 2018年6月5日

试验速览

暂无简介。

•-Age = 18 years
•-Diagnosis of RA as defined by the 1987-revised ACR classification criteria or the new ACR/Eular 2010 criteria for early RA
•-Early RA defined by a disease duration of = 1 year
•-Use of a reliable method of contraception for women of childbearing potential
•-Able and willing to give written informed consent and participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•-Previous treatment with methotrexate or leflunomide
•-Previous treatment with cyclophosfamide, azathioprine or cyclosporine
•-Previous treatment with sulphasalazine for more than 3 weeks
•-Previous treatment with hydroxychloroquine for more than 6 weeks
•-Previous treatment with corticoids or intra-articular glucocorticoïds within 4 weeks before treatment start or for more than 4 weeks
•-Previous treatment with an investigational drug for the treatment/prevention of RA
•-Contraindications for corticosteroids
•-Contraindications for methotrexate, sulphasalazine or leflunomide
•?known chronic hepatic disease (alcoholic, fibrosis, …)
•?known pulmonary interstitial disease or fibrosis
•?known chronic renal failure
•?history of malignant neoplasm within 5 years
•?hematologic problems at the discretion of the investigator
•-Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
•-Pregnancy, breastfeeding or no use of a reliable method of contraception
•-Alcohol or drug abuse

发起方

niversity Hospitals Leuven