NL-OMON49109招募中4 期
The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis - A randomized controlled trial - PREDMETH trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •- Primary systemic treatment indication being an extra pulmonary location of
- •sarcoidosis (e.g. cardiac of neurological)
- •- 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
- •severe acute or chronic infections, such as tuberculosis, HIV, parasitic
- •infections or other immunodeficiency syndromes
- •mouth, stomach or duodenal ulcers
研究者
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