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

NCT04314193 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • Sarcoidosis, Pulmonary

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Marlies Wijsenbeek, MD PhD · Erasmus Medical Center

  • Marcel Veltkamp, MD PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-08-13
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314193 on ClinicalTrials.gov