Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

Rheumatoid Arthritis Clinical Trial

Official title:

Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292456
• Other study ID #: KA- 21026
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Hacettepe University
• Contact: Melda Bahap, master of science
• Phone: +905398979922
• Email: melda_610[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Younger than 18

• Patients with communication disabilities

• Patients involved in another clinical and/or drug trial

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Glucocorticoids Toxicity
• Lupus Erythematosus, Systemic
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Vasculitis

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Each patient will be followed up for a total of 6 months, at 3 and 6 months.