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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03339102
Collaborator
(none)
158
Enrollment
17
Locations
29.7
Actual Duration (Months)
9.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    158 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 :
    Jan 25, 2018
    Actual Primary Completion Date :
    Jul 16, 2020
    Actual Study Completion Date :
    Jul 16, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Participants who received Humira®

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. Assessing Treatment Response [Up to follow-up week 22]

      Treatment response is assessed as improvement, no improvement and aggravation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03339102
    Other Study ID Numbers:
    • P17-176
    First Posted:
    Nov 13, 2017
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Panuveitis

    Study Results

    No Results Posted as of Jul 19, 2021