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

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Brief Title

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

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"

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.
    



Study Type

Observational


Primary Outcome

Percentage (%) of patients reported with serious adverse event

Secondary Outcome

 Change in Visual acuity

Condition

Non-infectious Intermediate, Posterior and Panuveitis


Study Arms / Comparison Groups

 Participants who received Humira®
Description:  Non-infectious intermediate, posterior, or panuveitis patients who received Humira®

Publications

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

Recruitment Information



Estimated Enrollment

158

Start Date

January 25, 2018

Completion Date

July 16, 2020

Primary Completion Date

July 16, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

19 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

AbbVie Inc., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03339102

Organization ID

P17-176


Responsible Party

Sponsor

Study Sponsor

AbbVie


Study Sponsor

AbbVie Inc., Study Director, AbbVie


Verification Date

August 2020