2024-514055-15-00招募中4 期
The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis - A randomized controlled trial
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)18 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年11月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 18
- 主要终点
- Change in hospital-measured Forced Vital Capacity
研究概览
简要总结
Investigate the effectiveness and tolerability of methotrexate as firstline therapy in patients with pulmonary sarcoidosis compared with prednisone.
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
- •Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria (7), in case of absent histology a diagnosis of sarcoidosis can also be established in a multidisciplinary team meeting in a sarcoidosis expert center based on a highly suggestive clinical and radiological picture (18, 19)
- •Age ≥18 years
- •A pulmonary indication for treatment and parenchymal involvement on X-ray or CT-scan conducted within three months before inclusion (determined by the treating physician and conform current guidelines)
- •A forced vital capacity (FVC) of ≤90% of predicted, or a diffusion capacity of the lung for carbon monoxide (DLCO) ≤70% of predicted, or ≥5% FVC decline/≥10% DLCO decline in the past year. For pulmonary functions tests GLI reference values are used.
排除标准
- •Any condition or circumstance that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures
- •Previous immunosuppressive treatment for sarcoidosis
- •Use of systemic immunosuppressive therapy within the preceding three months for another disease than sarcoidosis
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study treatment or within 90 days after the last dose in the randomized study phase. For males; planning to pro-create during the study or within 90 days after the last dose of the randomized study phase.
- •Contra-indication for methotrexate or corticosteroids: • severely impaired renal function (creatinine clearance <30 ml/min) • impaired hepatic function (serum bilirubin-value >5 mg/dl or 85,5 micromole/l) • bone marrow insufficiency with severe leukopenia, thrombocytopenia, or anaemia • severe acute or chronic infections, such as tuberculosis, HIV, parasitic infections or other immunodeficiency syndromes • mouth, stomach or duodenal ulcers
结局指标
主要结局
Change in hospital-measured Forced Vital Capacity
Change in hospital-measured Forced Vital Capacity
次要结局
- Biomarkers
研究者
Prof. dr. M.S. Wijsenbeek-Lourens
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (18)
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