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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Subcutaneous Injection
Peking University First Hospital /ID# 243055
Beijing, Beijing Municipality, China
Shanghai General hospital /ID# 247252
Shanghai, Shanghai Municipality, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 247251
Hangzhou, Zhejiang, China
Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253
Wenzhou, Zhejiang, China
Beijing Tongren Hospital, CMU /ID# 243054
Beijing, China
Tianjin Medical University Eye Hospital /ID# 243056
Tianjin, China
Xi'an people's hospital/Xi'an fourth hospital /ID# 243371
Xi'an, China
Percentage of participants that achieve quiescence in both eyes
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+
Time frame: Week 30
Percentage of participants that achieve no active lesions in both eyes
Percentage of participants that achieve no active lesions in both eyes.
Time frame: Week 30
Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes
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.
Time frame: Week 30
Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes
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.
Time frame: Week 30
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
Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA is measured using an ETDRS chart.
Time frame: Week 30
Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load
Achievement of a ≥ 50% reduction in immunosuppression load
Time frame: Week 30
Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg
Achievement of a systemic corticosteriods (CS) dose of ≤ 7.5 mg
Time frame: Week 30
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