Juvenile Idiopathic Arthritis (JIA)NCT06806774
Reliability and Validity of the Glittre Activities of Daily Living Test in Children and Adolescents With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before the age of 16 lasts for six weeks or more, and has an unknown cause. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of individuals with JIA who meet the inclusion criteria at the Department of Pediatrics, Division of Rheumatology, Hacettepe University Faculty of Medicine.
Who may be able to join
- Being diagnosed with Juvenile Idiopathic Arthritis (JIA) according to The International League of Associations for Rheumatology (ILAR) classification
- Being between the ages of 8-18
- Volunteering to participate in research
Who cannot join
- Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
- Having undergone major orthopedic surgery
- Not volunteering to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
Sinan Buran, MSc, +905076393104, pt.sinanburan@gmail.com
Edibe Ünal, Prof., +905327476706, edibeunal@yahoo.com
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
Sinan Buran, MSc, pt.sinanburan@gmail.com
About this study
Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before the age of 16 lasts for six weeks or more, and has an unknown cause. Despite the gains made in the management of the disease of individuals with JIA with modern medical treatment methods, the physical and psychosocial problems caused by chronic inflammation negatively affect the daily living activities of individuals with JIA. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that individuals with JIA reach a state of complete well-being, multi-interdisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools. However, these methods have disadvantages due to their subjectivity. In this case, objective measurement methods are needed to quantify the physical performance of patients with JIA in terms of their daily living activities. The Glittre Activities of Daily Living Test, initially developed by selecting activities similar to daily living activities to evaluate functional capacity in pulmonary diseases, has the potential to address this gap. Since the activities in the test require using both the lower and upper extremities, it has the advantage of reflecting functional capacity and providing information about performance in daily life activities. Although it has potential, the Glittre Activities of Daily Living Test needs appropriate psychometric properties for clinical settings and research for JIA patients. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Activities of Daily Living Test in assessing activities of daily living in children and adolescents with JIA.
Read the detailed description
Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before age 16, lasts six weeks or more, and has an unknown cause. Despite the gains made in the management of JIA patients with modern medical treatment methods, there are physical and psychosocial problems caused by chronic inflammation. While chronic pain, disease activity, fatigue, and musculoskeletal problems constitute the physical dimension of these effects, issues such as anxiety, depression, central sensitization of pain, decreased peer interaction, physical activity, and school participation constitute the psychosocial dimension. In a study that addressed these biopsychosocial problems holistically within the framework of the International Classification of Functioning Disability and Health - Children and Youth (ICF-CY), it was emphasized that the daily living activities of individuals diagnosed with JIA were negatively affected, resulting in participation restrictions in various environments. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that patients with JIA reach a state of complete well-being, multidisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools, especially the Childhood Health Assessment Questionnaire (CHAQ). CHAQ, widely used in evaluating daily living activities in pediatric rheumatology, stands out with its advantages, such as being practical, short, easy to score, and providing a commonly spoken language due to its adaptation to many languages. However, CHAQ also has some disadvantages. These disadvantages are that CHAQ is known for its ceiling effect, its subjective aspect, and its relative insensitivity to short-term changes. Physical function is a complex and multidimensional phenomenon associated with the ability to move and perform daily activities. Measuring physical function is essential to provide targets for clinical intervention to reduce impairments and increase participation in activities. By assessing physical function, baseline function can be objectively determined before treatment, which is essential for evaluating the effectiveness of the intervention. Physical function is usually measured with physical performance tests and self-report questionnaires. Physical performance tests quantify performance, as opposed to the perception of performance obtained through self-report questionnaires, thus providing a more objective measure of actual functional capacity. Performance-based measures have theoretical advantages over self-report measures, such as better repeatability, greater sensitivity to change, and less influence by external influences such as culture, language, and education. The "Glittre Activities of Daily Living Test," a physical function-based test that objectively evaluates daily living activities, was initially developed by selecting activities similar to daily living activities to assess functional capacity in Chronic Obstructive Pulmonary Disease. Since the activities in the Glittre Activities of Daily Living Test require using both the lower and upper extremities, the test has the advantages of reflecting functional capacity and providing information about performance in daily living activities. Due to these advantages, reliability and validity studies have been conducted on diseases other than chronic obstructive pulmonary disease, which was the starting point. The Glittre Activities of Daily Living Test rules were initially developed for adult patients and modified because they were unsuitable for the pediatric group. The modified test, the Pediatric Glittre Activities of Daily Living Test, was valid and reliable in children aged 6-14. One of the primary treatment goals is to ensure that patients with JIA maintain their daily living activities. Activities of daily living are also considered an important outcome measure for evaluating the course of the disease and the effectiveness of treatment. When the literature is examined, self-reporting questionnaires are used more frequently to assess the daily living activities of JIA patients, and performance-based standardized measurement methods are used less frequently. When considering the needs of individuals with JIA, the Glittre Activities of Daily Living Test has significant potential in this disease group. However, its psychometric properties must be appropriate in clinical settings and research. To our knowledge, no studies on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients have been conducted in the current literature. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Test of Activities of Daily Living in assessing activities of daily living in children and adolescents with JIA. Since the test is modified for 6-to 14-year-olds, the "Pediatric Glittre Activities of Daily Living Test" reliability and validity will be assessed in individuals with JIA within this age group. The standard version will be used for JIA patients between 15 and 18.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- activities of daily living, reliability, validity, juvenile idiopathic arthritis, functional capacity
- Medical subject headings
- Arthritis, Juvenile
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 |
|---|---|---|
| Juvenile Idiopathic Arthritis (JIA) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Glittre Activities of Daily Living Test
The Glittre Activities of Daily Living Test is widely used in the literature to evaluate activities of daily living based on performance. The test consists of a cycle of standardized activities such as walking, weight-bearing, climbing stairs, and moving objects on shelves. It is a test that takes place over a total distance of 10 m divided into two parts by a ladder. The person completes the test cycle in 5 laps at this distance range. The time it takes for individuals to complete the test and their pre-and post-test heart rate, blood pressure, respiratory frequency, SpO2, and modified Borg Scale, as well as their dyspnea and fatigue levels during exertion, are evaluated. In our study, the Pediatric Glittre Activities of Daily Living Test will be used for individuals diagnosed with JIA between the ages of 8 and 14, and the standard version of the test will be used for JIA patients between the ages of 15 and 18.
Measured: Baseline (First Assessment)
Secondary outcomes (5)
Functional Reach Test
The Functional Reach Test is a test that evaluates dynamic balance. The person is asked to stand with their arm at 90̊ flexion and close to the wall without touching it; then, they are instructed to reach forward as far as they can without taking a step. The difference between the start and finish is measured with a tape measure and recorded in centimeters. Three trials are performed; the average is the Functional Reach Test score.
Measured: Baseline (First assessment)
Six Minute Walk Test (6MWT)
For the 6MWT, individuals are asked to walk in a 30-meter corridor at the maximal speed they can walk without running. During the test, individuals are encouraged with standard expressions. At the end of the test, the distance covered will be recorded in meters. The individuals' pre-test and post-test heart rate, blood pressure, respiratory frequency, SpO2, and modified Borg Scale, as well as dyspnea and fatigue levels during exertion, will be evaluated.
Measured: Baseline (First Assessment)
Childhood Health Assessment Questionnaire (CHAQ)
The CHAQ assesses the functional abilities of children with JIA in activities of daily living. It comprises eight sections (dressing and grooming, arising, eating, walking, hygiene, reaching, griping, and activities) and evaluates pain (0: no pain and 10: extreme pain) and general well-being (0: no problem and 10: extreme problem) using a Visual Analog Scale. The total CHAQ score ranges from 0 to 3 (higher scores reflect low functionality).
Measured: Baseline (First Assessment)
Juvenile Arthritis Biopsychosocial Questionnaire (JAB-Q)
JAB-Q evaluates the problems experienced by both the child and the parent from a biopsychosocial perspective. The scale was developed initially in Turkish. It includes two separate forms for the child (patient) and parent (family) to complete. The child form consists of questions evaluating parameters such as pain intensity, disease activity, joint status, functional assessment, psychosocial status assessment, school status and fatigue, and is scored between 0 and 52 points. The family form includes parameters such as the parent's perception of health and psychosocial status and scores between 0 and 38. Forms can give both total scores and separate scores for subparameters. Higher scores indicate worse results.
Measured: Baseline (First Assessment)
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
JAQQ, a scale developed for patients with Juvenile Idiopathic Arthritis, consists of 74 items that assess various health domains, including physical functioning, emotional well-being, and general symptoms. The items are categorized into four dimensions related to the child's quality of life: gross motor function, fine motor function, psychosocial function, and systemic symptoms. The questionnaire provides separate scores for these four dimensions and a total score. All scores are scored between 0 and 7. Higher scores indicate a lower quality of life. Doğan et al. conducted the Turkish validity and reliability study of the questionnaire.
Measured: Baseline (First Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start10 Apr 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Buran, Hacettepe University
- Investigators
- Sinan Buran, MSc, Principal investigator, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806774
- Sponsor's protocol ID
- SBA 24/999
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2025
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Glittre Activities of Daily Living Test in Children and Adolescents With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06806774
- Acronym / sponsor ID
- SBA 24/999
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- activities of daily living, reliability, validity, juvenile idiopathic arthritis, functional capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before the age of 16 lasts for six weeks or more, and has an unknown cause. Despite the gains made in the management of the disease of individuals with JIA with modern medical treatment methods, the physical and psychosocial problems caused by chronic inflammation negatively affect the daily living activities of individuals with JIA. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that individuals with JIA reach a state of complete well-being, multi-interdisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools. However, these methods have disadvantages due to their subjectivity. In this case, objective measurement methods are needed to quantify the physical performance of patients with JIA in terms of their daily living activities. The Glittre Activities of Daily Living Test, initially developed by selecting activities similar to daily living activities to evaluate functional capacity in pulmonary diseases, has the potential to address this gap. Since the activities in the test require using both the lower and upper extremities, it has the advantage of reflecting functional capacity and providing information about performance in daily life activities. Although it has potential, the Glittre Activities of Daily Living Test needs appropriate psychometric properties for clinical settings and research for JIA patients. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Activities of Daily Living Test in assessing activities of daily living in children and adolescents with JIA.
Detailed description
Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before age 16, lasts six weeks or more, and has an unknown cause. Despite the gains made in the management of JIA patients with modern medical treatment methods, there are physical and psychosocial problems caused by chronic inflammation. While chronic pain, disease activity, fatigue, and musculoskeletal problems constitute the physical dimension of these effects, issues such as anxiety, depression, central sensitization of pain, decreased peer interaction, physical activity, and school participation constitute the psychosocial dimension. In a study that addressed these biopsychosocial problems holistically within the framework of the International Classification of Functioning Disability and Health - Children and Youth (ICF-CY), it was emphasized that the daily living activities of individuals diagnosed with JIA were negatively affected, resulting in participation restrictions in various environments. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that patients with JIA reach a state of complete well-being, multidisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools, especially the Childhood Health Assessment Questionnaire (CHAQ). CHAQ, widely used in evaluating daily living activities in pediatric rheumatology, stands out with its advantages, such as being practical, short, easy to score, and providing a commonly spoken language due to its adaptation to many languages. However, CHAQ also has some disadvantages. These disadvantages are that CHAQ is known for its ceiling effect, its subjective aspect, and its relative insensitivity to short-term changes. Physical function is a complex and multidimensional phenomenon associated with the ability to move and perform daily activities. Measuring physical function is essential to provide targets for clinical intervention to reduce impairments and increase participation in activities. By assessing physical function, baseline function can be objectively determined before treatment, which is essential for evaluating the effectiveness of the intervention. Physical function is usually measured with physical performance tests and self-report questionnaires. Physical performance tests quantify performance, as opposed to the perception of performance obtained through self-report questionnaires, thus providing a more objective measure of actual functional capacity. Performance-based measures have theoretical advantages over self-report measures, such as better repeatability, greater sensitivity to change, and less influence by external influences such as culture, language, and education. The "Glittre Activities of Daily Living Test," a physical function-based test that objectively evaluates daily living activities, was initially developed by selecting activities similar to daily living activities to assess functional capacity in Chronic Obstructive Pulmonary Disease. Since the activities in the Glittre Activities of Daily Living Test require using both the lower and upper extremities, the test has the advantages of reflecting functional capacity and providing information about performance in daily living activities. Due to these advantages, reliability and validity studies have been conducted on diseases other than chronic obstructive pulmonary disease, which was the starting point. The Glittre Activities of Daily Living Test rules were initially developed for adult patients and modified because they were unsuitable for the pediatric group. The modified test, the Pediatric Glittre Activities of Daily Living Test, was valid and reliable in children aged 6-14. One of the primary treatment goals is to ensure that patients with JIA maintain their daily living activities. Activities of daily living are also considered an important outcome measure for evaluating the course of the disease and the effectiveness of treatment. When the literature is examined, self-reporting questionnaires are used more frequently to assess the daily living activities of JIA patients, and performance-based standardized measurement methods are used less frequently. When considering the needs of individuals with JIA, the Glittre Activities of Daily Living Test has significant potential in this disease group. However, its psychometric properties must be appropriate in clinical settings and research. To our knowledge, no studies on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients have been conducted in the current literature. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Test of Activities of Daily Living in assessing activities of daily living in children and adolescents with JIA. Since the test is modified for 6-to 14-year-olds, the "Pediatric Glittre Activities of Daily Living Test" reliability and validity will be assessed in individuals with JIA within this age group. The standard version will be used for JIA patients between 15 and 18.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvenile Idiopathic Arthritis (JIA) | – | – |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of individuals with JIA who meet the inclusion criteria at the Department of Pediatrics, Division of Rheumatology, Hacettepe University Faculty of Medicine.
Key inclusion criteria (3 listed)
- Being diagnosed with Juvenile Idiopathic Arthritis (JIA) according to The International League of Associations for Rheumatology (ILAR) classification
- Being between the ages of 8-18
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
- Having undergone major orthopedic surgery
- Not volunteering to participate in the study
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
The Glittre Activities of Daily Living Test
Time frame: Baseline (First Assessment)
The Glittre Activities of Daily Living Test is widely used in the literature to evaluate activities of daily living based on performance. The test consists of a cycle of standardized activities such as walking, weight-bearing, climbing stairs, and moving objects on shelves. It is a test that takes place over a total distance of 10 m divided into two parts by a ladder. The person completes the test cycle in 5 laps at this distance range. The time it takes for individuals to complete the test and their pre-and post-test heart rate, blood pressure, respiratory frequency, SpO2, and modified Borg Scale, as well as their dyspnea and fatigue levels during exertion, are evaluated. In our study, the Pediatric Glittre Activities of Daily Living Test will be used for individuals diagnosed with JIA between the ages of 8 and 14, and the standard version of the test will be used for JIA patients between the ages of 15 and 18.
5 secondary outcomes
Functional Reach Test
Time frame: Baseline (First assessment)
Six Minute Walk Test (6MWT)
Time frame: Baseline (First Assessment)
Childhood Health Assessment Questionnaire (CHAQ)
Time frame: Baseline (First Assessment)
Juvenile Arthritis Biopsychosocial Questionnaire (JAB-Q)
Time frame: Baseline (First Assessment)
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
Time frame: Baseline (First Assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
Sinan Buran, MSc principal investigator
Hacettepe University Faculty of Physical Therapy and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Hacettepe University at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinan Buran, MSc (+905076393104, pt.sinanburan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Glittre Activities of Daily Living Test (time frame: Baseline (First Assessment)). 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 15 Apr 2025.