Autoimmune Bullous DermatosisNCT05525065
Investigating the Morbidity of Glucocorticoid Use in Patients With Autoimmune Bullous Diseases (AIBDs)
An observational study of Autoimmune Bullous Dermatosis and Glucocorticoids Toxicity, run by Premier Specialists, Australia at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Bullous Dermatosis, Glucocorticoids Toxicity
- What is being tested?
- GlucoCorticoid
- Type of treatment
- Pill or oral medicine
- How many people
- 138 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Feb 2019to 1 Sep 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to consent.
- Under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Nature and Prevalence of Glucocorticoid-related Morbidity in Patients With Autoimmune Bullous Disease (AIBD) Using the Glucocorticoid Toxicity Index (GTI)
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.
Read the 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.
- Being tested
- GlucoCorticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoCorticoidDrug
Glucocorticoid as calculated in prednisone oral equivalents.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: GlucoCorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Feb 2019
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Bullous DermatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Premier Specialists, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Steritas
- Responsible party
- Sponsor
- Investigators
- Dedee Murrell, MBBS, Study chair, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525065
- Sponsor's protocol ID
- ABDF-GTI2021
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Nature and Prevalence of Glucocorticoid-related Morbidity in Patients With Autoimmune Bullous Disease (AIBD) Using the Glucocorticoid Toxicity Index (GTI)
- ClinicalTrials.gov ID
- NCT05525065
- Acronym / sponsor ID
- ABDF-GTI2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Premier Specialists, AustraliaUniversity, hospital or other
- Collaborators
- Steritas
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with autoimmune bullous disease receiving glucocorticoids for the duration of the study | – | Drug: GlucoCorticoidPatients 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. |
| 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 | – | Drug: GlucoCorticoidPatients with autoimmune bullous disease who initially had glucocorticoid treatment at the first visit, and had ceased glucocorticoid use during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to consent.
- Under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoCorticoidGlucocorticoid as calculated in prednisone oral equivalents. | Drug | Patients with autoimmune bullous disease ceasing glucocorticoids during the study period, Patients with autoimmune bullous disease receiving glucocorticoids for the duration of the study |
Primary outcome
Glucocorticoid Toxicity Score
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dedee Murrell, MBBS study chair
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Bullous Dermatosis and Glucocorticoids Toxicity, run by Premier Specialists, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucocorticoid Toxicity Score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.