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

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, non-blinded, multi-center, non-inferiority trial designed to compare effectiveness and side-effects of methotrexate versus prednisolone as first-line therapy for pulmonary sarcoidosis..

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Longfonds; St. Antonius Hospital
• Treatments: Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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 decline/≥10% DLCO 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