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Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis
The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
Details
| Lead sponsor | The Affiliated Hospital Of Guizhou Medical University |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 10 |
| Start date | 2025-02 |
| Completion | 2028-02 |
Conditions
- Ankylosing Spondylitis
Interventions
- Secukinumab
- Adalimumab
Primary outcomes
- Assessment of SpondyloArthritis International Society 40 (ASAS 40) — week 52
Proportion of subjects achieving ASAS 40 at Week 52. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain. - ASAS40 — week 104
1\. Proportion of subjects achieving ASAS 40 at Week 104. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain. - Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) — week 104
The mSASSS is a method used to assess spinal damage and function in patients with ankylosing spondylitis. The assessment Items includes: * Vertebral Scoring: It evaluates the morphology of each vertebra from T1 to L5. Each vertebra is scored from 0 to 3 based on the presence and degree of squaring, erosions, and syndesmophytes. For example, 0 means normal vertebra, and 3 indicates severe structural changes. * Intervertebral Disc Scoring: The intervertebral discs between the vertebrae are also assessed. The score ranges from 0 to 2, depending on the presence and extent of disc space narrowing and bridging syndesmophytes. Total Score Calculation: The scores of all vertebrae and intervertebral discs are summed up to obtain the mSASSS total score. The higher the score, the more severe the spinal damage. - Spondyloarthritis Research Consortium of Canada (SPARCC) — week 104
The SPARCC assessment method is a valuable tool in the field of spondyloarthritis research and diagnosis. The assessment Items include: * Sacroiliac Joint Assessment: It evaluates the sacroiliac joints using magnetic resonance imaging (MRI). The assessment includes aspects such as bone marrow edema, erosion, and fatty infiltration in the sacroiliac joints. Each feature is scored based on its severity and extent. * Spinal Assessment: For the spine, SPARCC also uses MRI to assess inflammation. It focuses on detecting signs like vertebral corner inflammation (enthesitis) and discitis. Similar to the sacroiliac joint assessment, specific features are scored according to their characteristics. Scoring System: The total SPARCC score is obtained by summing up the scores of different items. Higher scores indicate more severe inflammation and greater disease activity.
Countries
China