Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04314193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2020-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017565', 'term': 'Sarcoidosis, Pulmonary'}, {'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, open-label, multi-center (17 hospitals in the Netherlands), single country, non-inferiority trial.\n\nRandomization 1:1 to oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) or oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks. Thereafter continuation of trial for 18 months on regular treatment (investigator decision).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '24 weeks after inclusion', 'description': 'Change in hospital-measured FVC between baseline and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '4 weeks', 'description': 'Change in hospital-measured FVC between baseline and 4 weeks.'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '16 weeks', 'description': 'Change in hospital-measured FVC between baseline and 16 weeks.'}, {'measure': 'Time to major pulmonary improvement measured by FVC', 'timeFrame': '24 weeks', 'description': '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. This will be determined on the home spirometry data.'}, {'measure': 'Change in FVC', 'timeFrame': '4 weeks', 'description': 'The percentage of patients with a 5 and 10% improvement or decline in FVC at 4 weeks.'}, {'measure': 'Change in FVC', 'timeFrame': '16 weeks', 'description': 'The percentage of patients with a 5 and 10% improvement or decline in FVC at 16 weeks.'}, {'measure': 'Change in FVC', 'timeFrame': '24 weeks', 'description': 'The percentage of patients with a absolute 5 and 10% improvement or decline in percent predicted FVC at 24 weeks.'}, {'measure': 'Change in DLCO', 'timeFrame': '4 weeks', 'description': 'The percentage of patients with a 10% or \\> 10% improvement or decline in DLCO at 4 weeks.'}, {'measure': 'Change in DLCO', 'timeFrame': '16 weeks', 'description': 'The percentage of patients with a 10% or \\> 10% improvement or decline in DLCO at 16 weeks.'}, {'measure': 'Change in DLCO', 'timeFrame': '24 weeks', 'description': 'The percentage of patients with a 10% or \\> 10% improvement or decline in DLCO at 24 weeks.'}, {'measure': 'Changes in Angiotensin-Converting Enzyme (ACE)', 'timeFrame': '2 years', 'description': 'Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in sACE levels during treatment', 'timeFrame': '2 years', 'description': 'Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in soluble interleukin-2 receptor (sIL-2R)', 'timeFrame': '2 years', 'description': 'Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in sIL-2R levels during treatment', 'timeFrame': '2 years', 'description': 'Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in extracellular vesicles during treatment', 'timeFrame': '2 years', 'description': 'Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in extracellular vesicles absolute numbers', 'timeFrame': '2 years', 'description': 'Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in protein expression levels in extracellular vesicles during treatment', 'timeFrame': '2 years', 'description': 'Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in protein expression levels in extracellular vesicles', 'timeFrame': '2 years', 'description': 'Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in T lymphocyte phenotypes during Treatment', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment.'}, {'measure': 'Between group changes in T lymphocyte phenotypes', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in T lymphocyte absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in T lymphocyte absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in the distribution of T lymphocytes during treatment', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in the distribution of T lymphocytes', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in dendritic cell phenotypes during Treatment', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in dendritic cell phenotypes', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in dendritic cell absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in dendritic cell absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in the distribution of dendritic cells during treatment', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in the distribution of dendritic cells', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in monocyte subset phenotypes during Treatment', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences in expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in monocyte subset phenotypes', 'timeFrame': '2 years', 'description': 'Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity).\n\nDifferences expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in monocyte absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in monocyte absolute cell numbers', 'timeFrame': '2 years', 'description': 'Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Changes in the distribution of monocytes during treatment', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients before, during and after treatment'}, {'measure': 'Between group changes in the distribution of monocytes', 'timeFrame': '2 years', 'description': 'Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate'}, {'measure': 'Correlation between biomarkers and clinical parameters', 'timeFrame': '2 years', 'description': 'The differences in percentage of biomarkers is compared with the differences in change of FVC and DLCOc.\n\nBiomarkers are measured in peripheral blood and include:\n\n* monocytes, measured by flow cytometry (MFI)\n* Th-cells, measured by flow cytometry (MFI)\n* dendritic cells, measured by flow cytometry (MFI)\n* Proteins, measured by ELISA (ng/ml)\n* Serum biomarkers (U/l)'}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline and 4 weeks after inclusion', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline and 16 weeks after inclusion', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline and 24 weeks after inclusion', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline and 1 year after inclusion', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': "The King's Sarcoidosis Questionnaire (KSQ)", 'timeFrame': 'baseline and 2 years after inclusion', 'description': "The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete."}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline and 4 weeks after inclusion', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline and 16 weeks after inclusion', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline and 24 weeks after inclusion', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline and 1 year after inclusion', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The Chronic Respiratory Questionnaire (CRQ)', 'timeFrame': 'baseline and 2 years after inclusion', 'description': 'The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline and 4 weeks after inclusion', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline and 16 weeks after inclusion', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline and 24 weeks after inclusion', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline and 1 year after inclusion', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The global rating of change scale (GRC)', 'timeFrame': 'baseline and 2 years after inclusion', 'description': 'The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \\<1 minute to complete.'}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline and 4 weeks after inclusion', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline and 16 weeks after inclusion', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline and 24 weeks after inclusion', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline and 1 year after inclusion', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)', 'timeFrame': 'baseline and 2 years after inclusion', 'description': "Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL."}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline and 4 weeks after inclusion', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline and 16 weeks after inclusion', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline and 24 weeks after inclusion', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline and 1 year after inclusion', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The Medical Research Council Dyspnea scale', 'timeFrame': 'Baseline and 2 years after inclusion', 'description': 'The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline and 4 weeks after inclusion', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline and 16 weeks after inclusion', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline and 24 weeks after inclusion', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline and 1 year after inclusion', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'The fatigue assessment scale (FAS)', 'timeFrame': 'Baseline and 2 years after inclusion', 'description': 'The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.'}, {'measure': 'Number of patients who discontinue/switch medication', 'timeFrame': 'During 24 weeks', 'description': 'Every week patients register whether they missed pills (and the amount of pills wasted). Discontinuation or switch of medication is registered both by patients and researchers.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': 'baseline', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': '4 weeks', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': '16 weeks', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': '24 weeks', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': '1 year', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}, {'measure': 'Patient Experience and Satisfaction with Medication questionnaire', 'timeFrame': '2 years', 'description': 'Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcoidosis', 'pulmonary', 'prednisone', 'methotrexate'], 'conditions': ['Sarcoidosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '40387020', 'type': 'DERIVED', 'citation': 'Kahlmann V, Janssen Bonas M, Moor CC, Grutters JC, Mostard RLM, van Rijswijk HNAJ, van der Maten J, Marges ER, Moonen LAA, Overbeek MJ, Koopman B, Loth DW, Nossent EJ, Wagenaar M, Kramer H, Wielders PLML, Bonta PI, Walen S, Bogaarts BAHA, Kerstens R, Overgaauw M, Veltkamp M, Wijsenbeek MS; PREDMETH Collaborators. First-Line Treatment of Pulmonary Sarcoidosis with Prednisone or Methotrexate. N Engl J Med. 2025 Jul 17;393(3):231-242. doi: 10.1056/NEJMoa2501443. Epub 2025 May 18.'}, {'pmid': '33076885', 'type': 'DERIVED', 'citation': 'Kahlmann V, Janssen Bonas M, Moor CC, van Moorsel CHM, Kool M, Kraaijvanger R, Grutters JC, Overgaauw M, Veltkamp M, Wijsenbeek MS; Collaborating investigators. Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study. BMC Pulm Med. 2020 Oct 19;20(1):271. doi: 10.1186/s12890-020-01290-9.'}]}, 'descriptionModule': {'briefSummary': '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 pulmonary sarcoidosis.', 'detailedDescription': '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 with pulmonary sarcoidosis, treatment is recommended in case of significant symptoms and/or impaired or deteriorating lung function. Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion.\n\nPrednisone is currently the first-choice therapy in pulmonary sarcoidosis and leads to short-term improvement of lung function. Unfortunately, prednisone has major side-effects and is associated with impaired QoL. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. The investigators hypothesize that first-line treatment with methotrexate is as effective as prednisone, with fewer side-effects and better QoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age ≥18 years.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Previous immunosuppressive treatment for sarcoidosis\n* Use of systemic immunosuppressive therapy within the preceding three months for another disease than sarcoidosis\n* 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.\n* Primary systemic treatment indication being an extra pulmonary location of sarcoidosis (e.g. cardiac of neurological)\n* Contra-indication for methotrexate or corticosteroids:\n\n * severely impaired renal function (creatinine clearance \\<30 ml/min)\n * impaired hepatic function (serum bilirubin-value \\>5 mg/dl or 85,5 micromole/l)\n * bone marrow insufficiency with severe leukopenia, thrombocytopenia, or anaemia\n * severe acute or chronic infections, such as tuberculosis, HIV, parasitic infections or other immunodeficiency syndromes\n * mouth, stomach or duodenal ulcers'}, 'identificationModule': {'nctId': 'NCT04314193', 'acronym': 'PREDMETH', 'briefTitle': 'Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL71782.078.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'methotrexate', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prednisone', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.', 'armGroupLabels': ['methotrexate']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.', 'armGroupLabels': ['prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5223 GZ', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '1007 MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1061 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6815 AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Ziekenhuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '7512 KZ', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9728 NT', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Martini Ziekenhuis', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medical Center Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '2262 BA', 'city': 'Leidschendam', 'country': 'Netherlands', 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.08167, 'lon': 4.39281}}, {'zip': '3425 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Venlo', 'country': 'Netherlands', 'facility': 'VieCuri Medical Center', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Marlies Wijsenbeek, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}, {'name': 'Marcel Veltkamp, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Antonius Hospital', 'class': 'OTHER'}, {'name': 'Longfonds', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marlies Wijsenbeek', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}