NCT04314193

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion.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.

Conditions

• Sarcoidosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Methotrexate	Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.
DRUG	Prednisone	Oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-08-13
• Completion: 2026-07-01
• First posted: 2020-03-19
• Last updated: 2025-03-26

Locations

17 sites across 1 country: Netherlands