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Not yet recruiting NCT06833112

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

Phase IV Interventional Ankylosing Spondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secukinumab, Adalimumab.
Who it may be relevant to
Registry conditions: Ankylosing Spondylitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis

Overview

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

Interventions

  • Drug Secukinumab
    The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.
  • Drug Adalimumab
    The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.

Primary outcome measures

  • Assessment of SpondyloArthritis International Society 40 (ASAS 40) [Time frame: week 52]
  • ASAS40 [Time frame: week 104]
  • Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [Time frame: week 104]
  • Spondyloarthritis Research Consortium of Canada (SPARCC) [Time frame: week 104]
Secondary outcome measures (12)
  • Assessment of SpondyloArthritis International Society 20 (ASAS20) [Time frame: week 12, week 24, week 52]
  • Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6) [Time frame: week 12, week 24, week 52]
  • Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR) [Time frame: week 12, week 24, week 52]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 [Time frame: week 12, week 24, week 52]
  • BASDAI [Time frame: week 12, week 24, week 52]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [Time frame: week 12, week 24, week 52]
  • Visual Analogue Scale (VAS) [Time frame: week 12, week 24, week 52]
  • Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Time frame: week 12, week 24, week 52]
  • tender joint count (TJC), swollen joint count(SJC) [Time frame: week 12, week 24, week 52]
  • Ankylosing Spondylitis Disease Activity Score based on C-reactive Protein (ASDAS-CRP) [Time frame: week 12, week 24, week 52]
  • Ankylosing Spondylitis Disease Activity Score based on Erythrocyte Sedimentation Rate (ASDAS-ESR) [Time frame: week 12, week 24, week 52]
  • Ankylosing Spondylitis Quality of Life (ASQoL) [Time frame: week 12, week 24, week 52]

Eligibility criteria

Inclusion criteria

  • Male or female at least 18 years old;
  • diagnosed with AS according to the 1984 New York Modified Criteria;
  • Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
  • BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
  • 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;
  • Voluntary treatment with adalimumab and secukinumab;
  • Appropriate contraceptive measures for women of childbearing age;
  • without other rheumatic diseases.
  • Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)

Exclusion criteria

  • With unstable vital signs, coma, mental and cognitive impairment;
  • Patients with severe systemic diseases and other serious chronic diseases;
  • Pregnant or lactating patients;
  • History of malignant tumor in the past 5 years;
  • Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
  • Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
  • Moderate to severe heart failure (New York Heart Association grade 3-4);
  • Allergic to any of the components of adalimumab (HS016) or secukinumab;
  • Subjects who are participating in clinical research of other drugs;
  • In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Affiliated Hospital of Guizhou Medical University — Guiyang

Identifiers

NCT: NCT06833112 · 2024114K

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗