A Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Participants Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate, Posterior, or Pan-Uveitis
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|ClinicalTrials.gov Identifier: NCT05414201|
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : July 26, 2022
Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU.
Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China.
Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Non-infectious Intermediate Posterior- or Pan-uveitis||Drug: Adalimumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Single-arm Study to Demonstrate the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Chinese Subjects Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate-, Posterior-, or Pan-uveitis|
|Actual Study Start Date :||July 7, 2022|
|Estimated Primary Completion Date :||October 10, 2023|
|Estimated Study Completion Date :||October 10, 2023|
Participants will receive a loading dose of Adalimumab 80mg SC at Baseline followed a week later by a dose of Adalimumab 40mg SC every other week.
Other Name: Humira
- Percentage of participants that achieve quiescence in both eyes [ Time Frame: Week 30 ]Quiescence is defined as no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤ 0.5+
- Percentage of participants that achieve no active lesions in both eyes [ Time Frame: Week 30 ]Percentage of participants that achieve no active lesions in both eyes.
- Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes [ Time Frame: Week 30 ]
Slit lamp examinations will be conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam will be used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells.
- Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes [ Time Frame: Week 30 ]
Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:
Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.
- Percentage of participants that achieve no worsening of Best Corrected Visual Acuity (BCVA) by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes [ Time Frame: Week 30 ]Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA is measured using an ETDRS chart.
- Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load [ Time Frame: Week 30 ]Achievement of a ≥ 50% reduction in immunosuppression load
- Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg [ Time Frame: Week 30 ]Achievement of a systemic corticosteriods (CS) dose of ≤ 7.5 mg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05414201
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Peking University First Hospital /ID# 243055||Not yet recruiting|
|Beijing, Beijing, China, 100034|
|Peking Union Medical College Hospital /ID# 243057||Not yet recruiting|
|Beijing, Beijing, China, 100730|
|Shanghai General hospital /ID# 247252||Not yet recruiting|
|Shanghai, Shanghai, China, 200080|
|The second Affiliated hospital of Zhejiang University school of Medicine /ID# 247251||Not yet recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Beijing Tongren Hospital, CMU /ID# 243054||Not yet recruiting|
|Beijing, China, 100730|
|The first affiliated hospital of chongqing medical university /ID# 242971||Not yet recruiting|
|Chongqing, China, 400016|
|Tianjin Medical University Eye Hospital /ID# 243056||Recruiting|
|Tianjin, China, 300384|
|Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253||Not yet recruiting|
|Wenzhou, China, 325612|
|Xi'an people's hospital/Xi'an fourth hospital /ID# 243371||Not yet recruiting|
|XI An, China, 710000|
|Study Director:||ABBVIE INC.||AbbVie|