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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339102
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease
Uveitis

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Study Type : Observational
Estimated Enrollment : 415 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Participants who received Humira®
Non-infectious intermediate, posterior, or panuveitis patients who received Humira®



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-infectious intermediate, posterior and panuveitis (NIIPPU) patients who had been prescribed with Humira® will be registered to the study in accordance with the drug approval status as well as the investigator's clinical judgment.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339102


Contacts
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Contact: Hyunjin Kim +82 2 3429 9241 hkim@abbvie.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03339102    
Other Study ID Numbers: P17-176
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Non-infectious intermediate, posterior and panuveitis
Post-Marketing Surveillance
Humira®
Additional relevant MeSH terms:
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Uveitis
Panuveitis
Uveal Diseases
Eye Diseases