A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy after Remission-Induction Therapy with Tocilizumab and Glucocorticoids in Subjects with Giant Cell Arteritis - MED3-201802

Rheinische Friedrich Wilhelms Universität Bonn0 个研究点目标入组 40 人开始时间: 2022年6月22日最近更新: 2024年8月21日

适应症

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•1. Subjects male or female, aged =18 years, 2. Written informed consent of the capable subject for voluntary participation in the study., 3. Diagnosis of GCA as confirmed by the investigator fulfilment (also in retro-spect) of the proposed extended 1990 classification criteria for GCA., 4. Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA, 5. GCA patients who have been treated with tocilizumab and in whom discontinuation of tocilizumab therapy has been decided by the treating rheumatologist, within standard treatment at the department of rheumatology are eligible., 6. Total tocilizumab therapy should have been at least 6 months before inclusion., 7. Patients should be in stable remission (defined as the absence of signs or symptoms of GCA and normal CRP <1mg/dl), off glucocorticoids for at least 1 months at screening., 8. Willing and able to inject methotrexate or placebo subcutaneously at randomization, 9. Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)

•1.Severe renal (glomerular filtration rate <30/min) failure, 2.Conditions other than GCA requiring continuous or intermittent treatment with oral or parenteral Glucocorticoids (GCs) unless the last exposure to GCs was >1 months before screening, 3.Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis), 4.Current treatment with any other conventional, biologic or targeted synthet-ic DMARD except tocilizumab, 5.Elevation of transaminases above three times the norm, 6.Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in this clinical trial., 7.Pregnant or breast feeding women, 8.Contraindications for therapy with metex®, as indicated in the summary of product characteristics

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