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| Name | Class |
|---|---|
| The Eye Hospital of Wenzhou Medical University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Shandong Eye Hospital | OTHER |
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This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues.
The study will be followed up in the screening-baseline period and at 4,8,12,18,24,36, and 48 weeks after the start of the study drug. The ETDRS letter number change of the best corrected visual acuity ( BCVA ) at 24 weeks compared with the baseline was used as the main indicator. The last follow-up was performed at 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADA+MMF group | Experimental | Adalimumab biosimilars with immunosuppressants therapy |
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| Corticosteroids+MMF group | Active Comparator | Corticosteroids with immunosuppressive therapyï¼› |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Biosimilars Injection | Drug | Adalimumab biosimilars: 80 mg was subcutaneously injected for the first time in the first week, and then 40 mg was subcutaneously injected every two weeks from the first week to the 48 th week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of ETDRS letter count for BCVA at week 24 from baseline | The best corrected visual acuity of the patient would be examined by the ETDRS visual acuity chart according to the visual acuity examination SOP. Change of ETDRS letter count for BCVA at week 24 from baseline were the main indicator, the outcome at other follow-up time points(Baseline, weeks 4, 8, 12, 18, 36, 48)would also be included in the outcome analysis. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with weight gain at week 24 from baseline | Patients would be instructed to remove shoes and heavy clothing for measurement, and weight gain is defined as a 5% increase from baseline. | week 24 |
| Time of treatment failures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Chi | Shenzhen Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Eye Hospital | Shenzhen | Guangdong | 518040 | China |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
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| Shenzhen Eye Hospital |
| OTHER |
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|
| Corticosteroid | Drug | Patients received no less than 1 mg / kg.d glucocorticoid at week 0, then implemented according to the standard reduction scheme. |
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| Immunosuppressive Agents | Drug | Mycophenolate mofetil 1g bid for more than 3 months, maintenance dose not less than 0.5g bid |
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Treatment failure is defined as an increase in the degree of inflammation in one or more of four areas, including choroidal and/or retinal vasculopathy, macular edema, anterior chamber cell grade, and vitreous opacity grade, assessed by the investigators from week 4 to the end of follow-up.
| week 24 |
| Number of treatment failures | Treatment failure is defined as an increase in the degree of inflammation in one or more of four areas, including choroidal and/or retinal vasculopathy, macular edema, anterior chamber cell grade, and vitreous opacity grade, assessed by the investigators from week 4 to the end of follow-up. | week 24 |
| Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline | The changes of each follow-up time point from the baseline are evaluated according to VFQ-25 visual function evaluation scale.To calculate an overall composite score for the VFQ-25, we will simply average the vision-targeted subscale scores, excluding the general health rating question.(100=best, 0=worst possible score) | week 24 |
| Change of anterior chamber inflammation at week 24 from baseline | Change of anterior chamber inflammation assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria. | week 24 |
| Change of vitreous opacity at week 24 from baseline | Change of vitreous opacity assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria. | week 24 |
| Change of the retinal and choroidal inflammation at week 24 from baseline | Change of the retinal and choroidal inflammation assessed by fluorescein angiography. | week 24 |
| Change of the thickness of retina and choroid in macular area at week 24 from baseline | Change of the thickness of retina and choroid in macular area evaluated by Optical Coherence Tomography (OCT) or Optical Coherence Tomography Angiography (OCTA). | week 24 |
| Occurrence of skin abnormalities at the end of study | The occurrence of skin abnormalities reported by research doctors based on adverse reaction evaluation criteria (CTCAE v5.0). | week 48 |
| Occurrence of hypertension at the end of study | The occurrence of hypertension assessed by electronic blood manometer based on adverse reaction evaluation criteria (CTCAE v5.0). | week 48 |
| Occurrence of hyperglycemia at the end of study | The occurrence of hyperglycemia assessed by venous blood glucose testing based on adverse reaction evaluation criteria (CTCAE v5.0). | week 48 |
| Occurrence of active tuberculosis infection at the end of study | The occurrence of active tuberculosis infection assessed by pulmonary X-ray examination and tuberculosis bacterial T cell detection and evaluated by research doctors. | week 48 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |