Ankylosing Spondylitis
Conditions
Interventions
Infliximab group:None
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2. Meets the New York AS classification criteria revised in 1984 (The New York criteria revised in 1984 was used as the gold standard for the diagnosis of AS, as follows: lumbodorsal pain and morning stiffness >= 3 months, reduced after activity, not relieved at rest; the lumbar spine is limited in flexion and lateral flexion; the range of thoracic activity is smaller than the reference value of normal people of the same age and gender; bilateral sacroiliac arthritis grade II-IV or unilateral sacroiliac arthritis grade III-IV; AS diagnostic criteria: meet Article 4, and at least meet any of Articles 1-3); 3. IL-17 inhibitors were ineffective (primary or secondary failure). Definition of primary failure: ASAS20 response was not achieved after receiving a standard dose of IL-17 inhibitor for at least 12 weeks. Definition of secondary failure: The initial treatment was effective (ASAS20 response), but the disease activity was aggravated again in the subsequent treatment, and the ASAS20 response was lost at 24 weeks/later. To determine (satisfy any one): lose ASAS20 in two consecutive visits; ASDAS-CRP rose >= 1.1 points and again >= 2.1; it is necessary to shorten the administration interval or increase the dose to restore the original efficacy after remission (ASDAS = 12 weeks. Determination (meet any): ASDAS-CRP increased from = 2.1; spinal pain score >= 4 and BASDAI >= 4 again; 4. Disease activity period: BASDAI >= 4 and spinal pain score >= 4, or ASDAS-CRP >= 2.1; 5. Voluntary signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to infliximab or any excipient (test group); 2. Patients who had previously used infliximab for ineffective treatment or discontinuation due to intolerance (experimental group); 3. Combined with other autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease that may affect the efficacy of observation; 4. Active or recent history of severe infection, including but not limited to active tuberculosis, hepatitis B (HBsAg positive and HBV-DNA positive), hepatitis C, HIV infection; 5. History of congestive heart failure (NYHA grade III/IV); 6. History or symptoms of demyelinating diseases (such as multiple sclerosis); 7. Having a history of malignant tumors or suffering from malignant tumors (except for cured basal cell carcinoma of the skin or cervical carcinoma in situ); 8. Women who are pregnant, lactating, or planning for pregnancy during the study period and within 6 months after the last administration; 9. Patients who had undergone major surgery within the past 3 months or planned to undergo major surgery during the study period; 10. Have a history of drug abuse or alcohol dependence; 11. There are any other serious or uncontrolled medical or mental illnesses that may affect the safety of subjects, compliance or interpretation of research data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS40 remission rate;Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score ( compared to baseline );Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein ( ASDAS-CRP );Bath Ankylosing Spondylitis Functional Index ( BASFI ) score ( compared to baseline );Incidence and type of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS20 / ASAS partial response rate;Infliximab antibody concentration; | — |
Countries
China
Contacts
Public ContactChen Dan
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed