Status:
ACTIVE_NOT_RECRUITING
Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
St. Antonius Hospital
Longfonds
Conditions:
Sarcoidosis, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pulmo...
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...
Eligibility Criteria
Inclusion
- 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 absolute decline/≥10% DLCO absolute decline in the past year. For pulmonary functions tests GLI reference values are used.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04314193
Start Date
June 1 2020
End Date
July 1 2026
Last Update
March 26 2025
Active Locations (17)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
2
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
3
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1061 AC
4
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ