Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis

Launched by THE AFFILIATED HOSPITAL OF GUIZHOU MEDICAL UNIVERSITY · Feb 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well two medications, adalimumab and secukinumab, work together to treat ankylosing spondylitis, a type of arthritis that primarily affects the spine and can cause pain and stiffness. The researchers want to find out if this combination is safe and effective for patients who haven’t had enough relief from their symptoms with traditional treatments, like nonsteroidal anti-inflammatory drugs (NSAIDs).

To be eligible for the study, participants need to be at least 18 years old and have been diagnosed with ankylosing spondylitis. They should have experienced poor results from at least two NSAIDs over a total of four weeks, or they may not be able to take these drugs due to side effects. Participants will be monitored closely throughout the study and will need to come in for regular visits. It's important to note that this study is not yet recruiting new participants, so if you or someone you know is interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female at least 18 years old;
• • 2. diagnosed with AS according to the 1984 New York Modified Criteria;
• • 3. Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
• • 4. BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
• • 5. Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
• • 6. Voluntary treatment with adalimumab and secukinumab;
• • 7. Appropriate contraceptive measures for women of childbearing age;
• • 8. without other rheumatic diseases.
• • 9. Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)
• Exclusion Criteria:
• • 1. With unstable vital signs, coma, mental and cognitive impairment;
• • 2. Patients with severe systemic diseases and other serious chronic diseases;
• • 3. Pregnant or lactating patients;
• • 4. History of malignant tumor in the past 5 years;
• • 5. Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
• • 6. Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
• • 7. Moderate to severe heart failure (New York Heart Association grade 3-4);
• • 8. Allergic to any of the components of adalimumab (HS016) or secukinumab;
• • 9. Subjects who are participating in clinical research of other drugs;
• • 10. In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.