ClinicalTrials.gg
CompletedNCT03339102Updated Jul 19, 2021

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

An observational study in Non-infectious Intermediate, Posterior and Panuveitis, sponsored by AbbVie. Completed at 17 sites in Korea, Republic of. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-19.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
158
Ages
19 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-infectious Intermediate, Posterior and Panuveitis

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Keywords

  • Non-infectious intermediate, posterior and panuveitis
  • Post-Marketing Surveillance
  • Humira®
03

In context

Panuveitis

39 studies on the registry are indexed under Panuveitis; 4 are open to participants now.

Browse Panuveitis studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis
  • Patients voluntarily signed a patient authorization \& 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

Exclusion Criteria:

  • A patient who are 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
158 participants (actual)

Groups and cohorts

  • Participants who received Humira®

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

06

What researchers measure

Primary outcomes

  1. Percentage (%) of patients reported with serious adverse event

    The patients reported with serious adverse event will be collected.

    Time frame: Up to Week 32

Secondary outcomes

  1. 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.

    Time frame: Up to follow-up week 22

  2. Assessing Presence /absence of new active inflammatory chorioretinal lesions

    Presence or absence of new active inflammatory chorioretinal lesions is assessed.

    Time frame: Up to follow-up week 22

  3. Assessing Treatment Response

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

    Time frame: Up to follow-up week 22

07

Study locations

17 sites
  • Pusan National University Hosp /ID# 202026
    Busan, Busan Gwang Yeogsi 49241, Korea, Republic of
  • Soon Chun Hyang University Cheonan Hospital /ID# 204551
    Cheonan, Chungcheongnamdo 31151, Korea, Republic of
  • Yeungnam University Med Ctr /ID# 201361
    Daegu, Daegu Gwang Yeogsi 42415, Korea, Republic of
  • Seoul National Univ Bundang ho /ID# 201657
    Seongnam, Gyeonggido 13620, Korea, Republic of
  • Ajou University Hospital /ID# 201516
    Suwon-si, Gyeonggido 16499, Korea, Republic of
  • HanGil Eye Hospital /ID# 201655
    Bupyeong, Incheon Gwang Yeogsi 21388, Korea, Republic of
  • Wonkwang University Hospital /ID# 204545
    Iksan, Jeonrabugdo 54538, Korea, Republic of
  • Gangnam Severance Hospital /ID# 202027
    Seoul, Seoul Teugbyeolsi 06273, Korea, Republic of
  • Samsung Medical Center /ID# 201515
    Seoul, Seoul Teugbyeolsi 06351, Korea, Republic of
  • Nune Eye Hospital /ID# 211613
    Seoul City, Seoul 06198, Korea, Republic of
  • Maryknoll Medical Center /ID# 201370
    Busan, 48972, Korea, Republic of
  • Chungbuk National Univ Hosp /ID# 204544
    Cheongju, 28644, Korea, Republic of
  • Apgujung St. Mary's Eye Center /ID# 210721
    Gangnam-gu, 06023, Korea, Republic of
  • Inje University Ilsan Paik Hos /ID# 204543
    Goyang, 10380, Korea, Republic of
  • Chosun University Hospital /ID# 204542
    Gwangju, 61453, Korea, Republic of
  • Seoul National University Hospital /ID# 201656
    Seoul, 03080, Korea, Republic of
  • Kim's Eye Hospital /ID# 205685
    Seoul, 07301, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03339102
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Jan 25, 2018
Primary completion
Jul 16, 2020
Completion
Jul 16, 2020
Last update
Jul 19, 2021

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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