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

Glucocorticoids Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05525065
• Other study ID #: ABDF-GTI2021
• Status: Active, not recruiting
• Start date: February 2, 2019
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2023
• Source: Premier Specialists, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucocorticoids Toxicity
• Skin Diseases

Intervention

Drug:
• GlucoCorticoid
Glucocorticoid as calculated in prednisone oral equivalents.

Locations

Country	Name	City	State
Australia	Premier Specialists	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Premier Specialists, Australia	Steritas

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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