Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03265405
Eligibility Criteria:
Inclusion Criteria:
1. Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung/mediastinal lymph nodes
2. Diagnosis of sarcoidosis made on cytological or histological samples
3. Having significant symptoms requiring immunosuppressive treatment and/or having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrathoracic manifestation of the disease requiring treatment with low-medium dose glucocorticoids
4. Onset of symptoms within two years of study entry
Exclusion Criteria:
1. Pregnant or lactating women
2. Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)
3. Having absolute contraindication for prednisone in a dose of 40 mg/day (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)
4. Unwilling to participate in the study
5. Having received glucocorticoids (prednisolone equivalent \>15 mg/day) for more than three weeks in the preceding two years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03265405
Study Brief:
Protocol Section:
NCT03265405