Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis (NCT04314193) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis
Netherlands138 participantsStarted 2020-06-01
Plain-language summary
This is a prospective, randomized, non-blinded, multi-center, non-inferiority trial designed to compare effectiveness and side-effects of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria, 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.
* 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 absolute decline/≥10% DLCO absolute decline in the past year. For pulmonary functions tests GLI reference values are used.
Exclusion Criteria:
* 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 pulmona…