The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis - A randomized controlled trial

Phase 4

Recruiting

• Conditions: Besnier-Boeck-Schaumann disease of the lung; Pulmonary sarcoidosis; 10038716

• Registration Number: NL-OMON49109
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 138

Inclusion Criteria

- Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria (7), 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 (18, 19)
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in hospital-measured Forced Vital Capacity (FVC) between baseline<br /><br>and 24 weeks...</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other pulmonary function parameters, biomarkers, adverse events, quality of<br /><br>life.</p><br>