METHOTREXATE for Pulmonary sarcoidosis

Inclusion criteria

• {"criterion_text":"-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)"}
• {"criterion_text":"-Age ≥18 years"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-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."}

Exclusion criteria

• {"criterion_text":"-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"}
• {"criterion_text":"-Previous immunosuppressive treatment for sarcoidosis"}
• {"criterion_text":"-Use of systemic immunosuppressive therapy within the preceding three months for another disease than sarcoidosis"}
• {"criterion_text":"-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."}
• {"criterion_text":"-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"}

Primary endpoints

• {"endpoint_text":"-Change in hospital-measured Forced Vital Capacity","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Biomarkers","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

16-11-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

3

Number Of Sites

18

Number Of Participants

132

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands