Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
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|ClinicalTrials.gov Identifier: NCT03339102|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : January 2, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||415 participants|
|Official 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"|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Participants who received Humira®
Non-infectious intermediate, posterior, or panuveitis patients who received Humira®
- Percentage (%) of patients reported with serious adverse event [ Time Frame: Up to Week 32 ]The patients reported with serious adverse event will be collected.
- 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.
- 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.
- Assessing Treatment Response [ Time Frame: Up to follow-up week 22 ]Treatment response is assessed as improvement, no improvement and aggravation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339102
|Contact: Hyunjin Kim||+82 2 3429 email@example.com|
|Study Director:||AbbVie Inc.||AbbVie|