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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 132

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.
- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis compared with prednisone.;Secondary Objective: 1.Examine (immunological) biomarkers of disease progression and chronicity.<br>2.Assess whether response to therapy can be predicted in individual patients. <br>3.Gain more insights into the underlying disease mechanism and potential new targets ;Primary end point(s): change in hospital-measured Forced Vital Capacity;Timepoint(s) of evaluation of this end point: Change between baseline and week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Biomarkers;Timepoint(s) of evaluation of this end point: Between baseline and week 24

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