Clinical trial NCT03339102: Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-infectious Intermediate, Posterior and Panuveitis
Keywords: Non-infectious intermediate, posterior and panuveitis
Post-Marketing Surveillance
Humira®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage (%) of patients reported with serious adverse event
timeFrame: Up to Week 32
Secondary outcomes:
measure: Change in Visual acuity
timeFrame: Up to follow-up week 22
measure: Assessing Presence /absence of new active inflammatory chorioretinal lesions
timeFrame: Up to follow-up week 22
measure: Assessing Treatment Response
timeFrame: Up to follow-up week 22
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hosp /ID# 202026
state: Busan Gwang Yeogsi
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital /ID# 204551
state: Chungcheongnamdo
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Med Ctr /ID# 201361
state: Daegu Gwang Yeogsi
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ Bundang ho /ID# 201657
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 201516
state: Gyeonggido
city: Bupyeong
country: Korea, Republic of
facility: HanGil Eye Hospital /ID# 201655
state: Incheon Gwang Yeogsi
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital /ID# 204545
state: Jeonrabugdo
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 202027
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 201515
state: Seoul Teugbyeolsi
city: Seoul City
country: Korea, Republic of
facility: Nune Eye Hospital /ID# 211613
state: Seoul
city: Busan
country: Korea, Republic of
facility: Maryknoll Medical Center /ID# 201370
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National Univ Hosp /ID# 204544
city: Gangnam-gu
country: Korea, Republic of
facility: Apgujung St. Mary's Eye Center /ID# 210721
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hos /ID# 204543
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 204542
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 201656
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital /ID# 205685
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: