Efficacy and safety of adalimumab in Behcet's disease-related uveitis

• Register: ChiCTR
• Last refreshed on: 4 November 2019
• Main ID: ChiCTR1900027147
• Date of registration: 2019-11-02
• Prospective Registration: Yes
• Primary sponsor: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University
• Public title: Efficacy and safety of adalimumab in Behcet's disease-related uveitis
• Scientific title: Efficacy and safety of adalimumab in Behcet's disease-related uveitis
• Date of first enrolment: 2020-01-01
• Target sample size: 1:30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=45155
• Study type: Interventional study
• Study design: Single arm
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Wenru Su
• Affiliation: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University

• Name: Zhaohao Huang
• Affiliation: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Recurrent oral ulcer, more than three times a year;Ocular uveitis;
2. At least one of the following three items is met: 1) genital ulcer: the patient or doctor finds genital ulcer; 2) skin involvement: erythema nodosum; pseudofolliculitis; papule; acne like nodule; 3) positive acupuncture test.
Exclusion criteria: Malignancy or systemic infectious diseases, including hepatitis B or C infection or tuberculosis.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Behcet's disease-related uveitis

Intervention(s)

1:Adalimumab;

Primary Outcome(s)

vision;anterior uveitis activity;

Secondary Outcome(s)

Intraocular pressure;Fundus vessels leakage;

Source(s) of Monetary Support

None

Ethics review

Status: Not approved
Approval date: 26/08/2013
Contact: