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Completed

NCT Number: NCT03339102

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

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.

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Key information

Conditions

Non-infectious Intermediate, Posterior and Panuveitis Eye Diseases Panuveitis Uveal Diseases Uveitis

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hosp /ID# 202026, Busan, Busan Gwang Yeogsi, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage (%) of patients reported with serious adverse event

    Time frame: Up to Week 32

    The patients reported with serious adverse event will be collected.

Secondary outcomes

  1. Change in Visual acuity

    Time frame: 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.

  2. Assessing Presence /absence of new active inflammatory chorioretinal lesions

    Time frame: Up to follow-up week 22

    Presence or absence of new active inflammatory chorioretinal lesions is assessed.

  3. Assessing Treatment Response

    Time frame: Up to follow-up week 22

    Treatment response is assessed as improvement, no improvement and aggravation.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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"

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2017
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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