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

NCT ID: NCT03339102

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2020-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Non-infectious Intermediate, Posterior and Panuveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who received Humira®

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Pusan National University Hosp /ID# 202026

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Soon Chun Hyang University Cheonan Hospital /ID# 204551

Cheonan, Chungcheongnam-do, South Korea

Site Status

Yeungnam University Med Ctr /ID# 201361

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Seoul National Univ Bundang ho /ID# 201657

Seongnam, Gyeonggido, South Korea

Site Status

Ajou University Hospital /ID# 201516

Suwon, Gyeonggido, South Korea

Site Status

HanGil Eye Hospital /ID# 201655

Bupyeong, Incheon Gwang Yeogsi, South Korea

Site Status

Wonkwang University Hospital /ID# 204545

Iksan, Jeonrabugdo, South Korea

Site Status

Nune Eye Hospital /ID# 211613

Seoul, Seoul, South Korea

Site Status

Gangnam Severance Hospital /ID# 202027

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 201515

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Maryknoll Medical Center /ID# 201370

Busan, , South Korea

Site Status

Chungbuk National Univ Hosp /ID# 204544

Cheongju-si, , South Korea

Site Status

Apgujung St. Mary's Eye Center /ID# 210721

Gangnam-gu, , South Korea

Site Status

Inje University Ilsan Paik Hos /ID# 204543

Goyang, , South Korea

Site Status

Chosun University Hospital /ID# 204542

Gwangju, , South Korea

Site Status

Seoul National University Hospital /ID# 201656

Seoul, , South Korea

Site Status

Kim's Eye Hospital /ID# 205685

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P17-176

Identifier Type: -

Identifier Source: org_study_id

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