The prospect, non-inferiority study comparing subcutaneous infliximab and adalimumab by evaluating the recurrence of non-infectious acute anterior uveitis in patients with moderate to severe ankylosing spondylitis patients who had prior acute anterior uveitis history

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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