Clinical trial NCT04088019: Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis; Uveitis (Manifestation)
Anti-Tuberculous Drug Reaction
Tuberculous Uveitis
Keywords: Idiopathic uveitis
IGRA positive
Type 1 interferon
Transcriptomic analysis
Anti-Tuberculosis Therapy
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic uveitis patients with IGRA positive registered from September 2019 at Cipto Mangunkusumo Hospital

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.

Eligibility criteria: Inclusion criteria:

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.
* 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

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)

Primary outcomes:
measure: Proportion of clinical improvement
timeFrame: 0, 14 days, 8 weeks, 3 months, 6 months, and 12 months
measure: The changes of type 1 interferon scoring in selected gene expression
timeFrame: 0, 14 days, 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
state: Jakarta
Study officials:
affiliation: Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia
name: Rina La Distia Nora
role: PRINCIPAL_INVESTIGATOR
References: