Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis

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