Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatm
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(2020) 20:271
STUDY PROTOCOL
Open Access
Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study Vivienne Kahlmann1†, Montse Janssen Bonás2†, Catharina C. Moor1, Coline H. M. van Moorsel2, Mirjam Kool1, Raisa Kraaijvanger2, Jan C. Grutters2,3, Mayka Overgaauw4, Marcel Veltkamp2,3†, Marlies S. Wijsenbeek1*† and Collaborating investigators
Abstract Background: Treatment of pulmonary sarcoidosis is recommended in case of significant symptoms, impaired or deteriorating lung function. Evidence-based treatment recommendations are limited and largely based on expert opinion. Prednisone is currently the first-choice therapy and leads to short-term improvement of lung function. Unfortunately, prednisone often has side-effects and may be associated with impaired quality of life. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. Objective: The primary objective of this trial is to investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis compared with prednisone. The primary endpoint of this study will be the change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks. Secondary objectives are to gain more insights in response to therapy in individual patients by home spirometry and patient-reported outcomes. Blood biomarkers will be examined to find predictors of response to therapy, disease progression and chronicity, and to improve our understanding of the underlying disease mechanism. (Continued on next page)
* Correspondence: [email protected] V. Kahlmann and M. Janssen Bonas share first authorship M. Veltkamp and M.S. Wijsenbeek share last authorship 1 Department of Respiratory Medicine, Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Erasmus Medical Center, Rotterdam, the Netherlands Full list of author information is available at the end of the article
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