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

The Affiliated Hospital Of Guizhou Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Adalimumab; Drug: Secukinumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06833112

2024114K

Details and patient eligibility

About

The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

treatment group

Experimental group

Description:

The subjects were treated with adalimumab (HS016) in combination with secukinumab

Treatment:

Drug: Secukinumab

Drug: Adalimumab