2022-501058-12-00招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to relapse during the 12 months treatment period
研究概览
简要总结
To assess efficacy of metex® on sustained remission of GCA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects male or female, aged ≥18 years
- •Written informed consent of the capable subject for voluntary participation in the study.
- •Diagnosis of GCA as confirmed by the investigator fulfilment (also in retro-spect) of the proposed extended 1990 classification criteria for GCA.
- •Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA
- •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.
- •Total tocilizumab therapy should have been at least 6 months before inclusion.
- •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.
- •Willing and able to inject methotrexate or placebo subcutaneously at randomization
- •Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
排除标准
- •Severe renal (glomerular filtration rate <30/min) failure
- •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
- •Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- •Current treatment with any other conventional, biologic or targeted synthet-ic DMARD except tocilizumab
- •Elevation of transaminases above three times the norm
- •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.
- •Pregnant or breast feeding women
- •Contraindications for therapy with metex®, as indicated in the summary of product characteristics
结局指标
主要结局
Time to relapse during the 12 months treatment period
Time to relapse during the 12 months treatment period
次要结局
- 1. Cumulative prednisone doses at months 6, 12 and 18
- 2. Number of flares per patient during the 12 months treatment period, Time to first, second and third relapse after randomization, Percentage of patients with a relapse at month 6 and 18 after discontinuation of tocilizumab
- 3. Patient reported outcomes including SF-36, FACIT-Fatigue, Patient Global Assessment of Disease Activity (PGA), Patient assessment of pain
- 4. Investigator reported outcomes including Eval-uator Global Assessment of disease activity (EGA)
- 5. Occurrence of symptoms and signs related to GCA
- 6. Number of vasculitic vessels and change of intima-media-values during the study
- 7. Prevelance of aortitis at baseline and month 12 and 18
- 8. Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 10mg/L) at every visit
- 9. Occurrence of adverse events and serious adverse events, incidence of glucocorticoid-related adverse events
研究者
PD Dr. med. Valentin S. Schäfer
Scientific
Rheinische Friedrich Wilhelms Universität Bonn
研究点 (1)
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