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Active, Not Recruiting

NCT Number: NCT04314193

Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sarcoidosis, Pulmonary Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Respiratory Tract Diseases Sarcoidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

Loading trial locations.

About this study

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 Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion.

Prednisone 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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 absolute decline/≥10% DLCO absolute 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

Treatment and study plan

methotrexate

Drug

Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.

Prednisone

Drug

Oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 24 weeks after inclusion

    Change in hospital-measured FVC between baseline and 24 weeks

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 4 weeks

    Change in hospital-measured FVC between baseline and 4 weeks.

  2. Forced Vital Capacity (FVC)

    Time frame: 16 weeks

    Change in hospital-measured FVC between baseline and 16 weeks.

  3. Time to major pulmonary improvement measured by FVC

    Time frame: 24 weeks

    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.

  4. Change in FVC

    Time frame: 4 weeks

    The percentage of patients with a 5 and 10% improvement or decline in FVC at 4 weeks.

  5. Change in FVC

    Time frame: 16 weeks

    The percentage of patients with a 5 and 10% improvement or decline in FVC at 16 weeks.

  6. Change in FVC

    Time frame: 24 weeks

    The percentage of patients with a absolute 5 and 10% improvement or decline in percent predicted FVC at 24 weeks.

  7. Change in DLCO

    Time frame: 4 weeks

    The percentage of patients with a 10% or > 10% improvement or decline in DLCO at 4 weeks.

  8. Change in DLCO

    Time frame: 16 weeks

    The percentage of patients with a 10% or > 10% improvement or decline in DLCO at 16 weeks.

  9. Change in DLCO

    Time frame: 24 weeks

    The percentage of patients with a 10% or > 10% improvement or decline in DLCO at 24 weeks.

  10. Changes in Angiotensin-Converting Enzyme (ACE)

    Time frame: 2 years

    Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients before, during and after treatment

  11. Between group changes in sACE levels during treatment

    Time frame: 2 years

    Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate

  12. Changes in soluble interleukin-2 receptor (sIL-2R)

    Time frame: 2 years

    Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients before, during and after treatment

  13. Between group changes in sIL-2R levels during treatment

    Time frame: 2 years

    Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate

  14. Changes in extracellular vesicles during treatment

    Time frame: 2 years

    Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients before, during and after treatment

  15. Between group changes in extracellular vesicles absolute numbers

    Time frame: 2 years

    Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate

  16. Changes in protein expression levels in extracellular vesicles during treatment

    Time frame: 2 years

    Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients before, during and after treatment

  17. Between group changes in protein expression levels in extracellular vesicles

    Time frame: 2 years

    Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate

  18. Changes in T lymphocyte phenotypes during Treatment

    Time frame: 2 years

    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).

    Differences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment.

  19. Between group changes in T lymphocyte phenotypes

    Time frame: 2 years

    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).

    Differences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  20. Changes in T lymphocyte absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment

  21. Between group changes in T lymphocyte absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  22. Changes in the distribution of T lymphocytes during treatment

    Time frame: 2 years

    Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment

  23. Between group changes in the distribution of T lymphocytes

    Time frame: 2 years

    Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  24. Changes in dendritic cell phenotypes during Treatment

    Time frame: 2 years

    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).

    Differences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment

  25. Between group changes in dendritic cell phenotypes

    Time frame: 2 years

    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).

    Differences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  26. Changes in dendritic cell absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment

  27. Between group changes in dendritic cell absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  28. Changes in the distribution of dendritic cells during treatment

    Time frame: 2 years

    Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment

  29. Between group changes in the distribution of dendritic cells

    Time frame: 2 years

    Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  30. Changes in monocyte subset phenotypes during Treatment

    Time frame: 2 years

    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).

    Differences in expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment

  31. Between group changes in monocyte subset phenotypes

    Time frame: 2 years

    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).

    Differences expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  32. Changes in monocyte absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment

  33. Between group changes in monocyte absolute cell numbers

    Time frame: 2 years

    Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  34. Changes in the distribution of monocytes during treatment

    Time frame: 2 years

    Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients before, during and after treatment

  35. Between group changes in the distribution of monocytes

    Time frame: 2 years

    Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate

  36. Correlation between biomarkers and clinical parameters

    Time frame: 2 years

    The differences in percentage of biomarkers is compared with the differences in change of FVC and DLCOc.

    Biomarkers are measured in peripheral blood and include:

    • monocytes, measured by flow cytometry (MFI)
    • Th-cells, measured by flow cytometry (MFI)
    • dendritic cells, measured by flow cytometry (MFI)
    • Proteins, measured by ELISA (ng/ml)
    • Serum biomarkers (U/l)

  37. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline

    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.

  38. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline and 4 weeks after inclusion

    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.

  39. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline and 16 weeks after inclusion

    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.

  40. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline and 24 weeks after inclusion

    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.

  41. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline and 1 year after inclusion

    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.

  42. The King's Sarcoidosis Questionnaire (KSQ)

    Time frame: baseline and 2 years after inclusion

    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.

  43. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline

    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.

  44. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline and 4 weeks after inclusion

    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.

  45. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline and 16 weeks after inclusion

    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.

  46. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline and 24 weeks after inclusion

    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.

  47. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline and 1 year after inclusion

    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.

  48. The Chronic Respiratory Questionnaire (CRQ)

    Time frame: baseline and 2 years after inclusion

    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.

  49. The global rating of change scale (GRC)

    Time frame: baseline

    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.

  50. The global rating of change scale (GRC)

    Time frame: baseline and 4 weeks after inclusion

    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.

  51. The global rating of change scale (GRC)

    Time frame: baseline and 16 weeks after inclusion

    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.

  52. The global rating of change scale (GRC)

    Time frame: baseline and 24 weeks after inclusion

    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.

  53. The global rating of change scale (GRC)

    Time frame: baseline and 1 year after inclusion

    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.

  54. The global rating of change scale (GRC)

    Time frame: baseline and 2 years after inclusion

    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.

  55. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline

    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.

  56. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline and 4 weeks after inclusion

    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.

  57. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline and 16 weeks after inclusion

    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.

  58. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline and 24 weeks after inclusion

    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.

  59. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline and 1 year after inclusion

    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.

  60. The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)

    Time frame: baseline and 2 years after inclusion

    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.

  61. The Medical Research Council Dyspnea scale

    Time frame: Baseline

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  62. The Medical Research Council Dyspnea scale

    Time frame: Baseline and 4 weeks after inclusion

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  63. The Medical Research Council Dyspnea scale

    Time frame: Baseline and 16 weeks after inclusion

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  64. The Medical Research Council Dyspnea scale

    Time frame: Baseline and 24 weeks after inclusion

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  65. The Medical Research Council Dyspnea scale

    Time frame: Baseline and 1 year after inclusion

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  66. The Medical Research Council Dyspnea scale

    Time frame: Baseline and 2 years after inclusion

    The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.

  67. The fatigue assessment scale (FAS)

    Time frame: Baseline

    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.

  68. The fatigue assessment scale (FAS)

    Time frame: Baseline and 4 weeks after inclusion

    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.

  69. The fatigue assessment scale (FAS)

    Time frame: Baseline and 16 weeks after inclusion

    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.

  70. The fatigue assessment scale (FAS)

    Time frame: Baseline and 24 weeks after inclusion

    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.

  71. The fatigue assessment scale (FAS)

    Time frame: Baseline and 1 year after inclusion

    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.

  72. The fatigue assessment scale (FAS)

    Time frame: Baseline and 2 years after inclusion

    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.

  73. Number of patients who discontinue/switch medication

    Time frame: During 24 weeks

    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.

  74. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: baseline

    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.

  75. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: 4 weeks

    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.

  76. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: 16 weeks

    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.

  77. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: 24 weeks

    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.

  78. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: 1 year

    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.

  79. Patient Experience and Satisfaction with Medication questionnaire

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Longfonds
  • St. Antonius Hospital

Registry information

Official study title

The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial

Acronym: PREDMETH

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Mar 19, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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