Tuberculosis; Uveitis (Manifestation)NCT04088019
Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive
An observational study of Tuberculosis; Uveitis (Manifestation) and Anti-Tuberculous Drug Reaction, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
The aim of this study is to determine the proportion of clinical improvement, the score changing of type 1 interferon selected gene expression, and analysis of transcriptomics profiling in patients with idiopathic uveitis positive IGRA before and after receiving Anti-Tuberculosis Therapy (ATT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis; Uveitis (Manifestation), Anti-Tuberculous Drug Reaction, Tuberculous Uveitis
- What is being tested?
- Fixed drug combination (FDC) of ATT and Oral steroid
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Oct 2019to Jul 2024
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Idiopathic uveitis patients with IGRA positive registered from September 2019 at Cipto Mangunkusumo Hospital
Who may be able to join
- Subjects who will be recruited to this study are patients who met the criteria described below:
- Registered patients from September 2019 at Cipto Mangunkusumo Hospital
- Idiopathic uveitis patients (proven having negative result by available etiological uveitis work-ups) with IGRA positive. IGRA positive value is defined by score above 0.35 u/ml obtained from Quantiferon Tuberculosis (QFT)-Gold Assay (QIAGEN).
- Minimum age: 18 years old
- Proven not having active Tuberculosis
- Not previously received Anti Tuberculosis Therapy.
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- Not consuming antibiotic one to two weeks prior to the time of study
- Not living together with Tuberculosis active patient
- Not having plan to become pregnant during the time of study
- Not part of reactive Tuberculosis risk group based on Latent Tuberculosis Incident WHO guidelines 2018
- Active inflammation in the past 180 days characterized by the following sign based on SUN Criteria(in at least one eye)
- ≥ 2+ anterior chamber cells
- ≥ 2+ vitreous haze
- active retinal or choroidal lesions
- Active inflammation during patient registration, characterized by the following sign based on SUN Criteria (in at least one eye)
- ≥1+ anterior chamber cells and/or
- ≥1+ vitreous haze and/or
- active retinal/choroidal lesions
Who cannot join
- Not willing to sign informed consent
- Pregnant patient
- Not coming to scheduled visit date
- Uveitis caused by infectious origin
- Media opacity caused by cataract and/ or corneal scar resulting in difficulty of posterior segment examination in both eyes
- Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes
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- History of prior intraocular surgery in < 30 days, or arranged surgery within the next 6 months
- Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye
- Any history of cancer excluding non-melanoma skin cancer
- Abnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment^
- Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment^
- Patient with active infection of tuberculosis, HIV infection, syphilis, or hepatitis B or C
- Note (^): Testing is conducted within 1-2 weeks prior to enrollment;
- As many 10 subjects of the health volunteers are recruited for this study after giving consent. The health volunteers that will be recruited are the subject who met following criteria:
- age: 18-50 years old (Man/Woman)
- not having any health complaint or symptoms
- not in any long term medication
- body mass index: 18.5 - < 30
- no history of allergy
- willing to cooperate in this study
- state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity (WHO healthy definition)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta Pusat, Jakarta Special Capital Region, 10430
Rina La Distia Nora, +62811198910, rina.ladistia@ui.ac.id
About this study
Official title: Proportion of Clinical Improvement and Score Comparison of Type 1 Interferon, Transcriptomic Analysis in Idiopathic Uveitis Patients With IGRA Positive Before and After Anti-Tuberculosis Drugs Treatment: Cohort Prospective Study
The aim of this study is to determine the proportion of clinical improvement, the score changing of type 1 interferon selected gene expression, and analysis of transcriptomics profiling in patients with idiopathic uveitis positive IGRA before and after receiving Anti-Tuberculosis Therapy (ATT).
Hopefully, by conducting this research, we are able to provide valid data that demonstrate the advantages/disadvantages usage of Anti-Tuberculosis Therapy in patients with idiopathic uveitis IGRA positive that correlate with type I IFN. This research is a part of our efforts in discovering bio-marker candidates of idiopathic uveitis IGRA positive clinical patients who will benefit from the ATT administration.
Read the detailed description
Diagnostic of Idiopathic Uveitis IGRA Positive patients were still unclear. This situation happens because it is still can't be explained if the uveitis from the patients was caused by mycobacterium tuberculosis or not which leads to doubtfulness for Anti-Tuberculosis Treatment (ATT). This study aims to help to provide evidence on whether ATT usage for Idiopathic Uveitis IGRA Positive would bring beneficial impact for the patients. This study will try to analyze the data from clinical improvements, Type 1 Interferon changes, and transcriptomics analysis from the patients.
- Conditions
- Tuberculosis; Uveitis (Manifestation), Anti-Tuberculous Drug Reaction, Tuberculous Uveitis
- Being tested
- Fixed drug combination (FDC) of ATT and Oral steroid
- Keywords
- Idiopathic uveitis, IGRA positive, Type 1 interferon, Transcriptomic analysis, Anti-Tuberculosis Therapy
- Medical subject headings
- Tuberculosis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed drug combination (FDC) of ATT and Oral steroidDrug
In the first two week, patients receive FDC of ATT only. Oral steroid start to be given in week three.
The ATT regiment is continued for up to 6 months or more, in accordance with WHO guidelines. In the first two months the antibiotic combination given consisted of isoniazid (INH), rifampicin, pyrazinamide, and ethambutol. The next four months or continuation phases, the ATT given is rifampicin and isoniazid.
The following dosage and administration of oral steroids will be given to patients, according to guidelines from the American Journal of Ophthalmologists (Douglas A. Jabs et al, 2000):
Initial dose: 1mg/kg/day, with maximum adult oral dose 60-80 mg/kg and maintenance dose less than or equal to 10 mg/day. The tapering schedule: Over 40 mg/day, decrease by 10 mg/day every 1-2 weeks, 40-20 mg/day, decrease by 5 mg/day every 1-2 weeks, 20-10 mg/day, decrease by 2.5 mg/day every 1-2 weeks, 10-0 mg/day, decrease by 1 to 2.5 mg/day every 1-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort group | Subjects: idiopathic uveitis with IGRA positive.
Examinations:
* Clinical improvement examinations at day 0, second week, week 8, month 3, month 6 and month 12.
* Blood sampling at day 0, second week, month 6 for analysing type 1 IFN gene expression scoring using RT-qPCR methods. Receives: Drug: Fixed drug combination (FDC) of ATT and Oral steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinical improvement
Clinical improvement of uveitis patients with IGRA positive after receiving complete Anti Tuberculosis Therapy is measured by using The Standardization of Uveitis Nomenclature (SUN) inflammation degree. Clinical improvement definition is decreasing of inflammation degree up to two degrees or becoming 0 degree. Meanwhile, clinical failure is defined by increasing of inflammation degree or decreasing of inflammation degree up to one degree/ not becoming 0 degree or unchanged degree of first to fourth degree.
Measured: 0, 14 days, 8 weeks, 3 months, 6 months, and 12 months
The changes of type 1 interferon scoring in selected gene expression
The score changes of type 1 interferon of uveitis patients with IGRA positive are determined by gene expression value of 10 varieties of type 1 interferon using Quantitative Reverse Transcriptase PCR (RT-qPCR) testing.
Measured: 0, 14 days, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start30 Oct 2019
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis; Uveitis (Manifestation)Studies 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rina, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Rina La Distia Nora, Principal investigator, Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088019
- Sponsor's protocol ID
- 19-06-0769
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportion of Clinical Improvement and Score Comparison of Type 1 Interferon, Transcriptomic Analysis in Idiopathic Uveitis Patients With IGRA Positive Before and After Anti-Tuberculosis Drugs Treatment: Cohort Prospective Study
- ClinicalTrials.gov ID
- NCT04088019
- Acronym / sponsor ID
- 19-06-0769
- Conditions
- Tuberculosis; Uveitis (Manifestation), Anti-Tuberculous Drug Reaction, Tuberculous Uveitis
- Keywords
- Idiopathic uveitis, IGRA positive, Type 1 interferon, Transcriptomic analysis, Anti-Tuberculosis Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 Sep 2019 (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.
The aim of this study is to determine the proportion of clinical improvement, the score changing of type 1 interferon selected gene expression, and analysis of transcriptomics profiling in patients with idiopathic uveitis positive IGRA before and after receiving Anti-Tuberculosis Therapy (ATT).
Hopefully, by conducting this research, we are able to provide valid data that demonstrate the advantages/disadvantages usage of Anti-Tuberculosis Therapy in patients with idiopathic uveitis IGRA positive that correlate with type I IFN. This research is a part of our efforts in discovering bio-marker candidates of idiopathic uveitis IGRA positive clinical patients who will benefit from the ATT administration.
Detailed description
Diagnostic of Idiopathic Uveitis IGRA Positive patients were still unclear. This situation happens because it is still can't be explained if the uveitis from the patients was caused by mycobacterium tuberculosis or not which leads to doubtfulness for Anti-Tuberculosis Treatment (ATT). This study aims to help to provide evidence on whether ATT usage for Idiopathic Uveitis IGRA Positive would bring beneficial impact for the patients. This study will try to analyze the data from clinical improvements, Type 1 Interferon changes, and transcriptomics analysis from the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort group | – | Drug: Fixed drug combination (FDC) of ATT and Oral steroidSubjects: idiopathic uveitis with IGRA positive. Examinations: * Clinical improvement examinations at day 0, second week, week 8, month 3, month 6 and month 12. * Blood sampling at day 0, second week, month 6 for analysing type 1 IFN gene expression scoring using RT-qPCR methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic uveitis patients with IGRA positive registered from September 2019 at Cipto Mangunkusumo Hospital
Key inclusion criteria (18 listed)
- Subjects who will be recruited to this study are patients who met the criteria described below:
- Registered patients from September 2019 at Cipto Mangunkusumo Hospital
- Idiopathic uveitis patients (proven having negative result by available etiological uveitis work-ups) with IGRA positive. IGRA positive value is defined by score above 0.35 u/ml obtained from Quantiferon Tuberculosis (QFT)-Gold Assay (QIAGEN).
- Minimum age: 18 years old
- Proven not having active Tuberculosis
Key exclusion criteria (21 listed)
- Not willing to sign informed consent
- Pregnant patient
- Not coming to scheduled visit date
- Uveitis caused by infectious origin
- Media opacity caused by cataract and/ or corneal scar resulting in difficulty of posterior segment examination in both eyes
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 |
|---|---|---|
| Fixed drug combination (FDC) of ATT and Oral steroidIn the first two week, patients receive FDC of ATT only. Oral steroid start to be given in week three. The ATT regiment is continued for up to 6 months or more, in accordance with WHO guidelines. In the first two months the antibiotic combination given consisted of isoniazid (INH), rifampicin, pyrazinamide, and ethambutol. The next four months or continuation phases, the ATT given is rifampicin and isoniazid. The following dosage and administration of oral steroids will be given to patients, according to guidelines from the American Journal of Ophthalmologists (Douglas A. Jabs et al, 2000): Initial dose: 1mg/kg/day, with maximum adult oral dose 60-80 mg/kg and maintenance dose less than or equal to 10 mg/day. The tapering schedule: Over 40 mg/day, decrease by 10 mg/day every 1-2 weeks, 40-20 mg/day, decrease by 5 mg/day every 1-2 weeks, 20-10 mg/day, decrease by 2.5 mg/day every 1-2 weeks, 10-0 mg/day, decrease by 1 to 2.5 mg/day every 1-4 weeks. | Drug | Observational cohort group |
Primary outcome
Proportion of clinical improvement
Time frame: 0, 14 days, 8 weeks, 3 months, 6 months, and 12 months
Clinical improvement of uveitis patients with IGRA positive after receiving complete Anti Tuberculosis Therapy is measured by using The Standardization of Uveitis Nomenclature (SUN) inflammation degree. Clinical improvement definition is decreasing of inflammation degree up to two degrees or becoming 0 degree. Meanwhile, clinical failure is defined by increasing of inflammation degree or decreasing of inflammation degree up to one degree/ not becoming 0 degree or unchanged degree of first to fourth degree.
The changes of type 1 interferon scoring in selected gene expression
Time frame: 0, 14 days, 6 months.
The score changes of type 1 interferon of uveitis patients with IGRA positive are determined by gene expression value of 10 varieties of type 1 interferon using Quantitative Reverse Transcriptase PCR (RT-qPCR) testing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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.
Rina La Distia Nora principal investigator
Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia
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 Tuberculosis; Uveitis (Manifestation) and Anti-Tuberculous Drug Reaction, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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 18 inclusion and 21 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 28 Feb 2024. 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 Indonesia. 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 Rina La Distia Nora (+62811-198-910, rina.ladistia@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of clinical improvement (time frame: 0, 14 days, 8 weeks, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. 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 28 Feb 2024.