Non-infectious Intermediate, Posterior and Panuveitis Clinical Trial
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"
| NCT number | NCT03339102 |
| Other study ID # | P17-176 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 25, 2018 |
| Est. completion date | July 16, 2020 |
| Verified date | July 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 158 |
| Est. completion date | July 16, 2020 |
| Est. primary completion date | July 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 99 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | HanGil Eye Hospital /ID# 201655 | Bupyeong | Incheon Gwang Yeogsi |
| Korea, Republic of | Maryknoll Medical Center /ID# 201370 | Busan | |
| Korea, Republic of | Pusan National University Hosp /ID# 202026 | Busan | Busan Gwang Yeogsi |
| Korea, Republic of | Soon Chun Hyang University Cheonan Hospital /ID# 204551 | Cheonan | Chungcheongnamdo |
| Korea, Republic of | Chungbuk National Univ Hosp /ID# 204544 | Cheongju | |
| Korea, Republic of | Yeungnam University Med Ctr /ID# 201361 | Daegu | Daegu Gwang Yeogsi |
| Korea, Republic of | Apgujung St. Mary's Eye Center /ID# 210721 | Gangnam-gu | |
| Korea, Republic of | Inje University Ilsan Paik Hos /ID# 204543 | Goyang | |
| Korea, Republic of | Chosun University Hospital /ID# 204542 | Gwangju | |
| Korea, Republic of | Wonkwang University Hospital /ID# 204545 | Iksan | Jeonrabugdo |
| Korea, Republic of | Seoul National Univ Bundang ho /ID# 201657 | Seongnam | Gyeonggido |
| Korea, Republic of | Gangnam Severance Hospital /ID# 202027 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Kim's Eye Hospital /ID# 205685 | Seoul | |
| Korea, Republic of | Samsung Medical Center /ID# 201515 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Seoul National University Hospital /ID# 201656 | Seoul | |
| Korea, Republic of | Nune Eye Hospital /ID# 211613 | Seoul City | Seoul |
| Korea, Republic of | Ajou University Hospital /ID# 201516 | Suwon-si | Gyeonggido |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage (%) of patients reported with serious adverse event | The patients reported with serious adverse event will be collected. | Up to Week 32 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Assessing Treatment Response | Treatment response is assessed as improvement, no improvement and aggravation. | Up to follow-up week 22 |