Uveitis Clinical Trial
Official title:
Efficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
Verified date | March 2021 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this single-center prospective study is to evaluate the efficacy and safety of Tocilizumab (TCZ), humanized monoclonal antibody against IL-6receptor, in the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on decreasing the dose of cortical steroids, and to determine whether it can reduce BDU recurrence.
Status | Terminated |
Enrollment | 3 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - All participants fulfill the the proposed International Criteria for BD, either ISG criteria(1990) or ICBD criteria(2013). - All participants present with refractory BDU , acute onset uveitis, either posterior segment involvement or panuveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants, without severe extraocular manifestations. Exclusion Criteria: - Patients with impaired hepatic and renal function, other severe ocular diseases, active tuberculosis, viral hepatitis, malignancy, pregnancy will be excluded. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Wenjie Zheng |
China,
Atienza-Mateo B, Calvo-Río V, Beltrán E, Martínez-Costa L, Valls-Pascual E, Hernández-Garfella M, Atanes A, Cordero-Coma M, Miquel Nolla J, Carrasco-Cubero C, Loricera J, González-Vela MC, Vegas-Revenga N, Fernández-Díaz C, Demetrio-Pablo R, Domínguez-Cas — View Citation
Lopalco G, Fabiani C, Sota J, Lucherini OM, Tosi GM, Frediani B, Iannone F, Galeazzi M, Franceschini R, Rigante D, Cantarini L. IL-6 blockade in the management of non-infectious uveitis. Clin Rheumatol. 2017 Jul;36(7):1459-1469. doi: 10.1007/s10067-017-36 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Tocilizumab on BD Uveitis | Remission or deterioration of uveitis,based on intraocular inflammation evaluation | four weeks | |
Secondary | Intraocular inflammation evaluation BOS24 index | Visual acuity, anterior chamber cells, vitreous opacities, retinal inflammation, macular thickness, etc. | each follow-up visit / every four weeks, up to six months | |
Secondary | Corticosteroid-tapering effects | Whether corticosteroid dosage could be tapered to minimum dose. | six months | |
Secondary | Reduction of uveitis recurrence | Differences of recurrence between before and after treatment | each follow-up visit / every four weeks, up to six months | |
Secondary | Severity of uveitis on recurrence | Differences of severity of recurrence between before and after treatment | each follow-up visit / every four weeks, up to six months | |
Secondary | Improvement of quality of life | Record quality of life on questionnaire: BDCAF | each follow-up visit / every four weeks, up to six months | |
Secondary | Improvement of quality of life | Record quality of life on questionnaire: SF-36 | each follow-up visit / every four weeks, up to six months | |
Secondary | Side effects of treatment | Record any side effects during intervention | each follow-up visit / every four weeks, up to six months |
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