Investigating the Morbidity of Glucocorticoid Use in Patients With Autoimmune Bullous Diseases (AIBDs)

NCT ID: NCT05525065

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2025-09-01

Brief Summary

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.

Detailed Description

This study is an multi-centre observational trial. Patients with AIBDs are recruited based on the 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), patients with receipt of previous oral glucocorticoid use with no current use (Group 2, steroid-sparing control group) or patients who had ceased glucocorticoids during the study (Group 3, ceased steroid 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.

Patients are considered for enrolment based on inclusion criteria after attendance at a bullous disease clinic at a participating study site. At the baseline visit (V1), patients are comprehensively interviewed for demographic factors (age, gender), pre-existing medical conditions, and past and current medications. Patients attend regular follow-up visits at three-month intervals, to a maximum follow-up period of 15 months (V6). Treatment plans, including glucocorticoid dose, are determined by accredited medical professionals based on the clinical condition of the patient.

The Glucocorticoid Toxicity Index (GTI) tool (Figure 1) is used to evaluate glucocorticoid toxicity at all visits, including in dermatologic, neuropsychiatric, musculoskeletal, endocrine and metabolic domains.

Myopathy was measured and graded in accordance to the GTI.

Patients were divided into three groups: Group 1 (control) comprised of patients was comprised of who were not exposed to glucocorticoids during the study period, Group 2 comprised of patients whose glucocorticoid dose was ceased during the study period. Patients who continued on glucocorticoid treatment for the duration of the study period formed the third group.

Conditions

Autoimmune Bullous Dermatosis; Glucocorticoids Toxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with autoimmune bullous disease receiving glucocorticoids for the duration of the study

Patients with autoimmune bullous disease currently receiving glucocorticoids for their condition, as independently assessed by an appropriately qualified medical professional/dermatologist, for the duration of the study period.

GlucoCorticoid

Intervention Type: DRUG

Glucocorticoid as calculated in prednisone oral equivalents.

Patients with autoimmune bullous disease not currently receiving glucocorticoids

Patients with autoimmune bullous disease who have received glucocorticoids for their condition in the past, but are not currently on steroids.

No interventions assigned to this group

Patients with autoimmune bullous disease ceasing glucocorticoids during the study period

Patients with autoimmune bullous disease who initially had glucocorticoid treatment at the first visit, and had ceased glucocorticoid use during the study period.

GlucoCorticoid

Intervention Type: DRUG

Glucocorticoid as calculated in prednisone oral equivalents.

Interventions

GlucoCorticoid

Glucocorticoid as calculated in prednisone oral equivalents.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steritas

UNKNOWN

Sponsor Role: collaborator

Premier Specialists, Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dedee Murrell, MBBS

Role: STUDY_CHAIR

University of New South Wales

Locations

Premier Specialists

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

ABDF-GTI2021

Identifier Type: -

Identifier Source: org_study_id