None listed
Conditions
Interventions
Drug : This study is prospective, open-label, multicenter, randomization(1:1), active controlled clinical trials. Up to 60 subjects (infliximab group 30, adalimumab group 30) will be enrolled.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate of AAU in AS patients treated with Infliximab or Adalimumab . The rate of recurrence will be evaluate as incidence rate per 100 patient-years and the number of recurrences (classified as 1 or 2 or more) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Ophthalmic Clinical Features in Patients with Acute Anterior Uveitis 1) Fluorescein angiography (FA): confirmation of the presence of retinal vasculitis, papillitis and cystoid macular edema (CME). 2) Optical coherence tomography (OCT): measure the macular thickness 3) Wide-angle fundus photography: Check the state of the central retina (optic nerve, macula) 4) Changes in best corrected visual acuity;Severity of acute anterior uveitis at the occurrence;Changes from baseline in ASDAS(Ankylosing Spondylitis Disease Activity Score)-CRP score;Changes from baseline in BASDAI(Bath Ankylosing Spondylitis Disease Activity Index) score;Changes from baseline in BASFI(Bath Ankylosing Spondylitis Functional Index) score;Safety evaluation (adverse event, vital sign, laboratory results) | — |
Countries
Korea, Republic of
Contacts
Public ContactYeunHong Seo
Asan Medical Center
Outcome results
None listed