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

NCT05525065 | Unknown

• 1 other identifier: ABDF-GTI2021
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Bullous Dermatosis; Glucocorticoids Toxicity

Outcome Measures

Primary Outcomes (1)

• Glucocorticoid Toxicity Score

  Glucocorticoid toxicity score as calculated by the glucocorticoid toxicity index (GTI) application licenced by Steritas. The final glucocorticoid toxicity index (GTI) score is comprised of two sub-scores. The GTI-cumulative worsening score (GTI-CWS) captures any additive glucocorticoid toxicities, transient or persistent, that are not present at baseline is scored from 0 to +439. The GTI-aggregate improvement score (GTI-AIS) assesses end-point toxicity comparative to baseline and is scored from -317 to +410; a negative score represents an improvement in toxicity, whilst a positive score indicates worsening toxicity.

  2 years

Study Arms (3)

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.

Drug: GlucoCorticoid

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.

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.

Drug: GlucoCorticoid

Interventions

GlucoCorticoid DRUG

Glucocorticoid as calculated in prednisone oral equivalents.

Patients with autoimmune bullous disease ceasing glucocorticoids during the study period; Patients with autoimmune bullous disease receiving glucocorticoids for the duration of the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune bullous disease who regularly attend a bullous clinic as part of their regular care. Patients who have either used glucocorticoids in the past or are currently using glucocorticoids.

You may qualify if:

• 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.

You may not qualify if:

• Inability to consent.
• Under 18 years of age.

Sponsors & Collaborators

• Premier Specialists, Australia: lead
• Steritas: collaborator

Study Sites (1)

Premier Specialists

Sydney, New South Wales, 2217, Australia

Location

MeSH Terms

Interventions

Glucocorticoids

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dedee Murrell, MBBS

  University of New South Wales

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: February 2, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)