Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients

Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients According to the Standard for Re-examination of New Drugs

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03339102

Enrollment

158

Registered

2017-11-13

Start date

2018-01-25

Completion date

2020-07-16

Last updated

2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious Intermediate, Posterior and Panuveitis

Keywords

Non-infectious intermediate, posterior and panuveitis, Post-Marketing Surveillance, Humira®

Brief summary

The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis * Patients voluntarily signed a patient authorization & informed consent form. * Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study. * Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.

Exclusion criteria

* A patient who are contraindications to originator adalimumab (Humira®) as listed on the approved Korean label. * A patient who is participating on other interventional clinical trials * Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.

Design outcomes

Primary

Measure	Time frame	Description
Percentage (%) of patients reported with serious adverse event	Up to Week 32	The patients reported with serious adverse event will be collected.

Secondary

Measure	Time frame	Description
Change in Visual acuity	Up to follow-up week 22	The change in visual acuity is assessed from the best corrected visual acuity achieved after the first dose on visual acuity chart in each eye.
Assessing Presence /absence of new active inflammatory chorioretinal lesions	Up to follow-up week 22	Presence or absence of new active inflammatory chorioretinal lesions is assessed.
Assessing Treatment Response	Up to follow-up week 22	Treatment response is assessed as improvement, no improvement and aggravation.

Countries

South Korea

Outcome results