Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT04314193
Eligibility Criteria:
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 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 anaemia
* severe acute or chronic infections, such as tuberculosis, HIV, parasitic infections or other immunodeficiency syndromes
* mouth, stomach or duodenal ulcers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04314193
Study Brief:
Protocol Section:
NCT04314193