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

Sarcoidosis, Pulmonary Clinical Trial

Official title: The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial

Status Active, not recruiting

Clinical Trial 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..

Clinical Trial Description

Sarcoidosis is a multisystem, granulomatous disorder, most commonly affecting the lungs. Symptom burden is high, and quality of life (QoL) and social participation are negatively affected. In patients with pulmonary sarcoidosis, treatment is recommended in case of significant symptoms and/or impaired or deteriorating lung function. Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion.

Prednisone is currently the first-choice therapy in pulmonary sarcoidosis and leads to short-term improvement of lung function. Unfortunately, prednisone has major side-effects and is associated with impaired QoL. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. The investigators hypothesize that first-line treatment with methotrexate is as effective as prednisone, with fewer side-effects and better QoL. ;

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

• NCT number: NCT04314193
• Study type: Interventional
• Source: Erasmus Medical Center
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 1, 2020
• Completion date: July 2026