Inflammatory or autoimmune disorders
Conditions
Brief summary
Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia [serum sodium < 135 millimole (mM)], hyperkalemia [serum potassium > 5 mM], hypoglycemia [plasma glucose < 3.5 mM]); whichever occurs first.
Detailed description
Time to first occurrence of individual components of the primary outcome, Cumulative overall systemic glucocorticoid dose, Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure, Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease, General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100, Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, and blood pressure, Performance in 250 mcg ACTH (Synacthen®) test, In patients hospitalized at study entry: length of hospital stay
Interventions
DRUGPREDNISONE
DRUGMarketing authorisation number: 6866372.00.00
DRUGATC-Code: V03AX10.
Sponsors
Kantonsspital Baden AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia [serum sodium < 135 millimole (mM)], hyperkalemia [serum potassium > 5 mM], hypoglycemia [plasma glucose < 3.5 mM]); whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of individual components of the primary outcome, Cumulative overall systemic glucocorticoid dose, Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure, Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease, General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100, Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, and blood pressure, Performance in 250 mcg ACTH (Synacthen®) test, In patients hospitalized at study entry: length of hospital stay | — |
Countries
Germany
Outcome results
None listed