The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis – A randomized controlled trial - PREDMETH trial

Erasmus Medisch Centrum Dept. of Pulmonology0 个研究点目标入组 132 人开始时间: 2019年11月15日最近更新: 2020年3月18日

试验速览

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•- 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.
•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 82
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- 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

发起方

Erasmus Medisch Centrum Dept. of Pulmonology