Table 1 Endpoints of the PREDMETH study listed as primary endpoint, secondary endpoints and explorative endpoints
Primary endpoint | |
 - Between-group difference in change in hospital-measured Forced Vital Capacity (FVC) % predicted between baseline and 24 weeks | |
Secondary endpoints | |
 - Difference in change in FVC % predicted at 4, 16 weeks, 1 year and 2 years between prednisone and methotrexate group  - Time to major pulmonary improvement measured by home-measured FVC, whereby major pulmonary improvement is defined as 80% of the maximum percent predicted FVC reached anywhere during the first 24 weeks of treatment  - The percentage of patients with ≥5 and ≥ 10% improvement or decline in FVC at 4, 16 and 24 weeks  - The percentage of patients with ≥10% improvement or decline in DLCO at 4, 16 and 24 weeks  - Change over time in (Health-related) quality of life measured by King’s Sarcoidosis Questionnaire (KSQ), Global Rating of Change scale (GRoC), Chronic Respiratory Questionnaire (CRQ) and Euroqol-5D-5L questionnaire (EQ-5D-5L) at every clinical visit  - Time to symptom improvement. Symptom scores measured by Visual Analogue Scales (VAS), Medical Research Council dyspnea scale (MRC) and Fatigue Assessment Scale (FAS)  - Expectations with medication at baseline  - Experiences and satisfaction with medication measured by the Patient Experience and Satisfaction with Medication Questionnaire (PESaM)  - Number, severity and impact of side-effects compared between methotrexate and prednisone  - Number of patients who discontinue/switch medication  - Adherence to treatment schedule (% of patients that received at least 90% of the total cumulative dose after 24 weeks).  - Correlation between angiotensin coverting enzyme (ACE), serum soluble interleukin-2 receptor (sIL-2R) and clinical parameters | |
Explorative endpoints | |
 - Asses predictors of disease progression and response to therapy  - Correlations between biomarker characteristics and clinical parameters  - Change in biomarkers over time  - Explore potential differences in distribution/phenotypes of monocytes, Th-cells, dendritic cells and new biomarkers identified using proteomics between patients during treatment with prednisone or methotrexate at all points |