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

July 13, 2021 updated by: AbbVie

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"

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48972
        • Maryknoll Medical Center /ID# 201370
      • Cheongju, Korea, Republic of, 28644
        • Chungbuk National Univ Hosp /ID# 204544
      • Gangnam-gu, Korea, Republic of, 06023
        • Apgujung St. Mary's Eye Center /ID# 210721
      • Goyang, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hos /ID# 204543
      • Gwangju, Korea, Republic of, 61453
        • Chosun University Hospital /ID# 204542
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 201656
      • Seoul, Korea, Republic of, 07301
        • Kim's Eye Hospital /ID# 205685
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49241
        • Pusan National University Hosp /ID# 202026
    • Chungcheongnamdo
      • Cheonan, Chungcheongnamdo, Korea, Republic of, 31151
        • Soon Chun Hyang University Cheonan Hospital /ID# 204551
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
        • Yeungnam University Med Ctr /ID# 201361
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Seoul National Univ Bundang ho /ID# 201657
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 201516
    • Incheon Gwang Yeogsi
      • Bupyeong, Incheon Gwang Yeogsi, Korea, Republic of, 21388
        • HanGil Eye Hospital /ID# 201655
    • Jeonrabugdo
      • Iksan, Jeonrabugdo, Korea, Republic of, 54538
        • Wonkwang University Hospital /ID# 204545
    • Seoul
      • Seoul City, Seoul, Korea, Republic of, 06198
        • Nune Eye Hospital /ID# 211613
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
        • Gangnam Severance Hospital /ID# 202027
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 201515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants who received Humira®
Non-infectious intermediate, posterior, or panuveitis patients who received Humira®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage (%) of patients reported with serious adverse event
Time Frame: Up to Week 32
The patients reported with serious adverse event will be collected.
Up to Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to follow-up week 22
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.
Up to follow-up week 22
Assessing Treatment Response
Time Frame: Up to follow-up week 22
Treatment response is assessed as improvement, no improvement and aggravation.
Up to follow-up week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P17-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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