Besnier-Boeck-Schaumann disease of the lung Pulmonary sarcoidosis
Conditions
Interventions
Treatment with prednisone or methotrexate.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 =5% FVC decline/>=10% DLCO decline in the past year. For pulmonary functions tests GLI reference values are used.
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks... | — |
Secondary
| Measure | Time frame |
|---|---|
| Other pulmonary function parameters, biomarkers, adverse events, quality of life. | — |
Countries
Netherlands
Outcome results
None listed