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

Completed

• Conditions: Non-infectious Intermediate, Posterior and Panuveitis

• Registration Number: NCT03339102
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-01-25
• Primary Completion: 2020-07-16
• Study Completion: 2020-07-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage (%) of patients reported with serious adverse event	Up to Week 32	The patients reported with serious adverse event will be collected.

Secondary Outcome Measures

Name	Time	Method
Change in Visual acuity	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 Treatment Response	Up to follow-up week 22	Treatment response is assessed as improvement, no improvement and aggravation.
Assessing Presence /absence of new active inflammatory chorioretinal lesions	Up to follow-up week 22	Presence or absence of new active inflammatory chorioretinal lesions is assessed.

Trial Locations

Locations (17)

Yeungnam University Med Ctr /ID# 201361; 🇰🇷 Daegu, Daegu Gwang Yeogsi, Korea, Republic of

Pusan National University Hosp /ID# 202026; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Soon Chun Hyang University Cheonan Hospital /ID# 204551; 🇰🇷 Cheonan, Chungcheongnamdo, Korea, Republic of

HanGil Eye Hospital /ID# 201655; 🇰🇷 Bupyeong, Incheon Gwang Yeogsi, Korea, Republic of

Ajou University Hospital /ID# 201516; 🇰🇷 Suwon-si, Gyeonggido, Korea, Republic of

Gangnam Severance Hospital /ID# 202027; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 201515; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Wonkwang University Hospital /ID# 204545; 🇰🇷 Iksan, Jeonrabugdo, Korea, Republic of

Nune Eye Hospital /ID# 211613; 🇰🇷 Seoul City, Seoul, Korea, Republic of

Maryknoll Medical Center /ID# 201370; 🇰🇷 Busan, Korea, Republic of

Apgujung St. Mary's Eye Center /ID# 210721; 🇰🇷 Gangnam-gu, Korea, Republic of

Chungbuk National Univ Hosp /ID# 204544; 🇰🇷 Cheongju, Korea, Republic of

Inje University Ilsan Paik Hos /ID# 204543; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Hospital /ID# 201656; 🇰🇷 Seoul, Korea, Republic of

Kim's Eye Hospital /ID# 205685; 🇰🇷 Seoul, Korea, Republic of

Chosun University Hospital /ID# 204542; 🇰🇷 Gwangju, Korea, Republic of

Seoul National Univ Bundang ho /ID# 201657; 🇰🇷 Seongnam, Gyeonggido, Korea, Republic of