PREDNISONE for Inflammatory or autoimmune disorders

Inclusion criteria

• {"criterion_text":"- Informed Consent as documented by signature"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion"}
• {"criterion_text":"- Therapy over ≥ 28 days,"}
• {"criterion_text":"- ≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion,"}
• {"criterion_text":"- cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion"}
• {"criterion_text":"- Tapering not or no longer mandatory to treat underlying disease"}

Exclusion criteria

• {"criterion_text":"- Primary adrenal failure"}
• {"criterion_text":"- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion."}
• {"criterion_text":"- Known or suspected non-compliance"}
• {"criterion_text":"- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,"}
• {"criterion_text":"- Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption."}
• {"criterion_text":"- Participation in another study with investigational drug within the 30 days preceding and during the present study,"}
• {"criterion_text":"- Previous enrolment into the current study,"}
• {"criterion_text":"- Enrolment of the investigator, his/her family members, employees and other dependent persons"}
• {"criterion_text":"- Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural)"}
• {"criterion_text":"- Incapability to administer glucocorticoid cover treatment in situations of stress"}
• {"criterion_text":"- Inability or unwillingness to provide informed consent"}
• {"criterion_text":"- Women who are pregnant or breast feeding,"}
• {"criterion_text":"- Intention to become pregnant during the course of the study,"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite time-to-event endpoint: time to first occurrence of any listed event. Adrenal crisis defined by glucocorticoid-responsive hypotension or shock with or without listed accompanying symptoms and specific laboratory thresholds for hyponatremia, hyperkalemia, and hypoglycemia."}

Secondary endpoints

• {"endpoint_text":"- Time to first occurrence of individual components of the primary outcome","definition_or_measurement_approach":"Time-to-event for each component (hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, adrenal crisis) analysed separately."}
• {"endpoint_text":"- Cumulative overall systemic glucocorticoid dose","definition_or_measurement_approach":"Summed systemic glucocorticoid dose over defined follow-up period."}
• {"endpoint_text":"- Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure","definition_or_measurement_approach":"Summed glucocorticoid dose specifically given for treatment or prevention of adrenal insufficiency events."}
• {"endpoint_text":"- Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease","definition_or_measurement_approach":"Disease-specific summed glucocorticoid dose for relapse treatment."}
• {"endpoint_text":"- General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100","definition_or_measurement_approach":"Participant-reported VAS from 0 to 100 assessing general health status."}
• {"endpoint_text":"- Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, and blood pressure","definition_or_measurement_approach":"Symptom/sign score assessing presence/severity of listed features of hypocortisolism and blood pressure measurements."}
• {"endpoint_text":"- Performance in 250 mcg ACTH (Synacthen®) test","definition_or_measurement_approach":"Biochemical assessment using 250 mcg ACTH stimulation test (Synacthen®) to evaluate adrenocortical function."}
• {"endpoint_text":"- In patients hospitalized at study entry: length of hospital stay","definition_or_measurement_approach":"Duration (days) of hospital stay for those hospitalized at baseline."}

Germany

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

442

Number Of Sites

2

Number Of Participants

25

Switzerland

Primary sponsor

Full Name

Kantonsspital Baden AG

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Switzerland