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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

∙ 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

Locations
Other Locations
Indonesia
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
RECRUITING
Jakarta Pusat
Contact Information
Primary
Rina La Distia Nora
rina.ladistia@ui.ac.id
+62811-198-910
Time Frame
Start Date: 2019-10-30
Estimated Completion Date: 2024-07
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fakultas Kedokteran Universitas Indonesia

This content was sourced from clinicaltrials.gov

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