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Table 2 Inclusion and exclusion criteria

From: Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study

Inclusion criteria Exclusion criteria
- Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria [6], 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 [22]
- Age ≥ 18 years
- A pulmonary indication for treatment and parenchymal involvement on X-ray or chest CT-scan conducted within three months before inclusion (determined by the treating physician and according to 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 an absolute decline of ≥5% FVC decline, or an absolute ≥10% DLCO decline in the past year
- 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 corticosteroidsa
  1. aContra-indications for methotrexate or corticosteroids are defined as: severely impaired renal function (creatinine clearance < 30 ml/min), impaired hepatic function (serum bilirubin-value > 5 mg/dl or 85,5 μmol/l), bone marrow insufficiency with severe leukopenia, thrombocytopenia, or anaemia, severe acute or chronic infections, such as tuberculosis, human immunodeficiency virus, parasitic infections or other immunodeficiency syndromes, mouth, stomach or duodenal ulcers