Glucocorticoids ToxicityNCT05292456
Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc
An observational study of Glucocorticoids Toxicity and Rheumatoid Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glucocorticoids Toxicity, Rheumatoid Arthritis, Vasculitis
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of RA, SLE or vasculitis followed in the Hacettepe University Hospitals Rheumatology Outpatient Clinic and receiving glucocortioid therapy will be included in the study.
Who may be able to join
- 18 years and over
- Individuals who have received glucocorticoid treatment for RA, SLE or vasculitis in the last 2 years or at current admission.
- Patients approved by the physician to participate in the study
- Patients giving written consent
Who cannot join
- Younger than 18
- Patients with communication disabilities
- Patients involved in another clinical and/or drug trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Melda Bahap, master of science, 05398979922, melda_610@hotmail.com
About this study
Official title: Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc
Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids.
Hypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients.
Read more
Hypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented.
The aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.
Read the detailed description
In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.
- Keywords
- glucocorticoid toxicity index, Drug-Related Problem, Glucocorticoid, Rheumatoid Arthritis, Vasculitis, Clinical Pharmacist
- Medical subject headings
- Arthritis, Rheumatoid, Vasculitis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA, SLE, and vasculitis patients who have just started glucocorticoid treatment | Not described | |
| RA, SLE and vasculitis patients receiving glucocorticoid treatment for the last 2 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Glucocorticoid Toxicity Index (GTI) scores
In this study, it is predicted that a change in GTI scores will be achieved during 3-month follow-up in patients with long-term and newly diagnosed RA, SLE and vasculitis. When the 6-month follow-up of each patient is completed, the study will be terminated.
In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.
Measured: Each patient will be followed up for a total of 6 months, at 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Feb 2021
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucocorticoids ToxicityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melda Bahap, Hacettepe University
- Investigators
- Omer Karadag, prof. doctor, Study director, Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292456
- Sponsor's protocol ID
- KA- 21026
- Status last verified
- Aug 2022
- First submitted
- 14 Mar 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bahap-Kara M, Sariyildiz E, Zengin HY, Karadag O, Bayraktar-Ekincioglu A. Prospective assessment of glucocorticoid toxicity in rheumatology practice: a focus on the glucocorticoid toxicity index. Rheumatology (Oxford). 2025 Mar 1;64(3):1010-1018. doi: 10.1093/rheumatology/keae288.
PubMed 38781534
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc
- ClinicalTrials.gov ID
- NCT05292456
- Acronym / sponsor ID
- KA- 21026
- Keywords
- glucocorticoid toxicity index, Drug-Related Problem, Glucocorticoid, Rheumatoid Arthritis, Vasculitis, Clinical Pharmacist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Mar 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.
Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids.
Hypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients.
Hypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented.
The aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.
Detailed description
In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA, SLE, and vasculitis patients who have just started glucocorticoid treatment | – | – |
| RA, SLE and vasculitis patients receiving glucocorticoid treatment for the last 2 years | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of RA, SLE or vasculitis followed in the Hacettepe University Hospitals Rheumatology Outpatient Clinic and receiving glucocortioid therapy will be included in the study.
Key inclusion criteria (4 listed)
- 18 years and over
- Individuals who have received glucocorticoid treatment for RA, SLE or vasculitis in the last 2 years or at current admission.
- Patients approved by the physician to participate in the study
- Patients giving written consent
Key exclusion criteria (3 listed)
- Younger than 18
- Patients with communication disabilities
- Patients involved in another clinical and/or drug trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in Glucocorticoid Toxicity Index (GTI) scores
Time frame: Each patient will be followed up for a total of 6 months, at 3 and 6 months.
In this study, it is predicted that a change in GTI scores will be achieved during 3-month follow-up in patients with long-term and newly diagnosed RA, SLE and vasculitis. When the 6-month follow-up of each patient is completed, the study will be terminated. In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 38781534Bahap-Kara M, Sariyildiz E, Zengin HY, Karadag O, Bayraktar-Ekincioglu A. Prospective assessment of glucocorticoid toxicity in rheumatology practice: a focus on the glucocorticoid toxicity index. Rheumatology (Oxford). 2025 Mar 1;64(3):1010-1018. doi: 10.1093/rheumatology/keae288.
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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.
Omer Karadag, prof. doctor study director
Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,
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 Glucocorticoids Toxicity and Rheumatoid Arthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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 3 Aug 2022. 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 Turkey (Türkiye). 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?
Contact Melda Bahap, master of science (+905398979922, melda_610@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Glucocorticoid Toxicity Index (GTI) scores (time frame: Each patient will be followed up for a total of 6 months, at 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292456, which also lists 1 linked publication.
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 3 Aug 2022.