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

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: Completed
• Conditions: Non-infectious Intermediate, Posterior and Panuveitis

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of patients reported with serious adverse event	The patients reported with serious adverse event will be collected.	Up to Week 32

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 16, 2020

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Humira®; Post-Marketing Surveillance; Non-infectious intermediate, posterior and panuveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveitis; Uveal Diseases; Panuveitis
• Other Study ID 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