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

Brief Title

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

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 Type

Observational [Patient Registry]


Primary Outcome

Proportion of clinical improvement


Condition

Tuberculosis; Uveitis (Manifestation)

Intervention

Fixed drug combination (FDC) of ATT and Oral steroid

Study Arms / Comparison Groups

 Observational cohort group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

October 2019

Completion Date

September 2020

Primary Completion Date

May 2020

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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Rina La Distia Nora, +62811-198-910, [email protected]

Location Countries

Indonesia

Location Countries

Indonesia

Administrative Informations


NCT ID

NCT04088019

Organization ID

19-06-0769


Responsible Party

Principal Investigator

Study Sponsor

Fakultas Kedokteran Universitas Indonesia


Study Sponsor

Rina La Distia Nora, Principal Investigator, Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia


Verification Date

October 2019