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Clinical trial

Investigating the Nature and Prevalence of Glucocorticoid-related Morbidity in Patients With Autoimmune Bullous Disease (AIBD) Using the Glucocorticoid Toxicity Index (GTI)

ID
Name
ABDF-GTI2021
Description
This project utilised the validated glucocorticoid toxicity index (GTI) tool to assess the morbidity of glucocorticoid-use in patients with autoimmune bullous disease. In particular, the study investigated the nature and prevalence of glucocorticoid-induced myopathy.
Trial arms
Trial start
2019-02-02
Estimated PCD
2023-09-01
Trial end
2025-09-01
Status
Active (not recruiting)
Treatment
GlucoCorticoid
Glucocorticoid as calculated in prednisone oral equivalents.
Arms:
Patients with autoimmune bullous disease ceasing glucocorticoids during the study period, Patients with autoimmune bullous disease receiving glucocorticoids for the duration of the study
Size
138
Primary endpoint
Glucocorticoid Toxicity Score
2 years
Eligibility criteria
Inclusion Criteria: * An age of eighteen years or above. * A new or established diagnosis of autoimmune bullous disease confirmed by clinical assessment, histopathology, immunofluorescence, and enzyme-linked immunoassay (ELISA) or biochip testing * New or current use of oral glucocorticoids for the treatment of autoimmune bullous disease (Group 1, active treatment group), or patients with receipt of previous oral glucocorticoid use with no current use (Group 2, steroid-sparing control group) * Attendance of at least one baseline visit (V1) and one follow-up visit during the study period; and, the provision of capacitated and informed consent. Exclusion Criteria: * Inability to consent. * Under 18 years of age.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 138, 'type': 'ESTIMATED'}}
Updated at
2023-08-31

1 organization

1 product

2 indications

Organization
Premier Specialists
Product
GlucoCorticoid
Indication
Autoimmune Bullous Dermatosis
Indication
Glucocorticoids Toxicity