KCT0007239招募中未知
The recurrence of acute anterior uveitis in patients treated with subcutaneous infliximab or adalimumab for ankylosing spondylitis having prior acute anterior uveitis: randomized control trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years to 65 years old
- •2.Patients with a diagnosis of severe AS
- •[Definition of severe AS]
- •Based on the Modified New York criteria 1984, radiological criteria and at least two clinical criteria (paragraph (1) must be included) are simultaneously satisfied, and the Bath Ankylosing Spondylitis Disease (BASDAI) Activity Index) is at least 4 or higher
- •* Radiological criteria: Sacroiliitis: Bilateral Grade 2 or higher, Unilateral Grade 3 or 4
- •* Clinical criteria
- •1) Low back pain and stiffness for more than 3 months that improves with exercise but does not improve with rest
- •2) Restriction of lumbar motion in both the sagittal and frontal planes
- •3) Restriction of chest expansion
- •3. Patients with a history of acute anterior uveitis (AAU) within 2 years prior to enrollment
- •4.Patients who voluntarily consented to this study and have written a informed consent.
排除标准
- •1.Patients who have been treated with TNF inhibitors other than etanercept within 2 years of enrollment
- •2.Patients with a history of hypersensitivity to humanized proteins
- •3.Patients with active tuberculosis
- •- However, patients with a history of tuberculosis who have proven to be cured after anti-tuberculosis treatment according to standard tuberculosis treatment guidelines can be enrolled.
- •4.Patients with latent tuberculosis
- •-Patients diagnosed with latent tuberculosis by performing at least one of history taking, physical examination, chest X-ray, PPD skin test, or interferon gamm a release assay (IGRA) during the screening period
- •-However, patients with latent tuberculosis who have completed treatment for latent tuberculosis for 4 weeks and plan to complete treatment for latent tuberculosis in the future can be enrolled.
- •5.Patients with hepatitis B or hepatitis C
- •6.Patients with a history of or positive for HIV infection
- •7.Patients with NYHA Class III/IV heart disease
- •8.Patients with a history of infection, malignancy (excluding basal cell carcinoma, cutaneous squamous cell carcinoma, cervical cancer) or dysplasia of the colon or small intestine within the previous 5 years
- •9.Pregnant or lactating women
- •10.Women of childbearing potential who do not use an appropriate method of contraception and do not plan to do so during the study period (hormonal contraceptives in oral, injectable, or implant form, diaphragms, condoms, intrauterine devices, or abstinence are recognized as appropriate methods of contraception)
- •11.Patients who are considered inadequate for the study based on investigator’s discretion
研究者
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