Non-infectious Intermediate, Posterior and PanuveitisNCT03339102
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
An observational study of Non-infectious Intermediate, Posterior and Panuveitis, run by AbbVie at 17 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Non-infectious Intermediate, Posterior and Panuveitis
- How many people
- 158 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 25 Jan 2018to 16 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
HanGil Eye Hospital /ID# 201655
Bupyeong, Incheon Gwang Yeogsi, 21388
Pusan National University Hosp /ID# 202026
Busan, Busan Gwang Yeogsi, 49241
Maryknoll Medical Center /ID# 201370
Busan, 48972
Soon Chun Hyang University Cheonan Hospital /ID# 204551
Cheonan, Chungcheongnam-do, 31151
Chungbuk National Univ Hosp /ID# 204544
Cheongju-si, 28644
Yeungnam University Med Ctr /ID# 201361
Daegu, Daegu Gwang Yeogsi, 42415
Apgujung St. Mary's Eye Center /ID# 210721
Gangnam-gu, 06023
Inje University Ilsan Paik Hos /ID# 204543
Goyang, 10380
Chosun University Hospital /ID# 204542
Gwangju, 61453
Wonkwang University Hospital /ID# 204545
Iksan, Jeonrabugdo, 54538
Seoul National Univ Bundang ho /ID# 201657
Seongnam, Gyeonggido, 13620
Nune Eye Hospital /ID# 211613
Seoul, Seoul, 06198
Gangnam Severance Hospital /ID# 202027
Seoul, Seoul Teugbyeolsi, 06273
Samsung Medical Center /ID# 201515
Seoul, Seoul Teugbyeolsi, 06351
Seoul National University Hospital /ID# 201656
Seoul, 03080
Kim's Eye Hospital /ID# 205685
Seoul, 07301
Ajou University Hospital /ID# 201516
Suwon, Gyeonggido, 16499
About this study
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"
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.
- Keywords
- Non-infectious intermediate, posterior and panuveitis, Post-Marketing Surveillance, Humira®
- Medical subject headings
- Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants who received Humira® | Non-infectious intermediate, posterior, or panuveitis patients who received Humira® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of patients reported with serious adverse event
The patients reported with serious adverse event will be collected.
Measured: Up to Week 32
Secondary outcomes (3)
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.
Measured: 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.
Measured: Up to follow-up week 22
Assessing Treatment Response
Treatment response is assessed as improvement, no improvement and aggravation.
Measured: Up to follow-up week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start25 Jan 2018
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Intermediate, Posterior and PanuveitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339102
- Sponsor's protocol ID
- P17-176
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2017
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03339102
- Acronym / sponsor ID
- P17-176
- Keywords
- Non-infectious intermediate, posterior and panuveitis, Post-Marketing Surveillance, Humira®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who received Humira® | – | –Non-infectious intermediate, posterior, or panuveitis patients who received Humira® |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage (%) of patients reported with serious adverse event
Time frame: Up to Week 32
The patients reported with serious adverse event will be collected.
3 secondary outcomes
Change in Visual acuity
Time frame: Up to follow-up week 22
Assessing Presence /absence of new active inflammatory chorioretinal lesions
Time frame: Up to follow-up week 22
Assessing Treatment Response
Time frame: Up to follow-up week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Non-infectious Intermediate, Posterior and Panuveitis
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Active, not recruitingPhase 3
A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis
Uveitis, Posterior, Uveitis, Intermediate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-infectious Intermediate, Posterior and Panuveitis, run by AbbVie at 17 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of patients reported with serious adverse event (time frame: Up to Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.