Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA

Ruhr-Universität Bochum0 个研究点目标入组 450 人开始时间: 2013年7月29日最近更新: 2018年7月23日

试验速览

暂无简介。

•Diagnosis of rheumatoid arthritis based on expert opinion according to the ACR/EULAR 2009 criteria (Hawker 2009), disease duration < 3 years, active disease: DAS 28 ESR (Prevoo et al 1995) > 4 plus = 3 swollen joints
•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 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 225

•Prior treatment with DMARDs (except for hydroxychloroquin or sulfasalazine or methotrexate during the last four weeks before screening)
•Clinically relevant comorbidity:
•concurrent liver disease (ALT > 2 times upper limit of normal),
•active hepatitis B or C viral infection,
•renal disease (creatinine clearance < 30 ml/minute),
•clinically relevant haematological disease due to the
•judgement of the rheumatologist,
•uncontrolled diabetes mellitus,
•relevant immunodeficiency incl. HIV-infection,
•clinically significant pulmonary fibrosis,
•presence or history of severe infections,
•pregnancy or planned pregnancy,
•non-compliance,
•age < 18 years.

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