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

NCT04088019 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Tuberculosis; Uveitis (Manifestation)
  • Anti-Tuberculous Drug Reaction
  • Tuberculous Uveitis

Interventions

DRUG

Fixed drug combination (FDC) of ATT and Oral steroid

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.

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Rina La Distia Nora · Division of Ophthalmology Departement, Faculty of Medicine Universitas Indonesia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088019 on ClinicalTrials.gov