Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive

Recruiting

• Conditions: Tuberculosis; Uveitis (Manifestation); Tuberculous Uveitis; Anti-Tuberculous Drug Reaction
• Interventions: Drug: Fixed drug combination (FDC) of ATT and Oral steroid

• Registration Number: NCT04088019
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief 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).

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 Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-10-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• 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
• 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:

1. age: 18-50 years old (Man/Woman)
2. not having any health complaint or symptoms
3. not in any long term medication
4. body mass index: 18.5 - < 30
5. no history of allergy
6. willing to cooperate in this study
7. state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity (WHO healthy definition)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational cohort group	Fixed drug combination (FDC) of ATT and Oral steroid	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.

Primary Outcome Measures

Name	Time	Method
Proportion of clinical improvement	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	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.

Trial Locations

Locations (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta Pusat, Jakarta, Indonesia