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The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | The subjects were treated with adalimumab (HS016) in combination with secukinumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg,q8w,subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis International Society 40 (ASAS 40) | 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:
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. | week 52 |
| ASAS40 | 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:
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. | week 104 |
| Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) | The mSASSS is a method used to assess spinal damage and function in patients with ankylosing spondylitis. The assessment Items includes:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis International Society 20 (ASAS20) | Proportion of subjects achieving ASAS 40 at week 12, week 24, week 52. ASAS 20 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 20% improvement in disease activity. Key Components of ASAS20: -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 ASAS20 responder if they achieve at least a 20% improvement or an absolute improvement of ≥1 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiashun Zeng, Medical Doctor | Contact | 13984846802 | zengjiashun@sina.com | |
| Pengjia Wu, Master | Contact | 15085969933 | 1015066791@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiashun Zeng, Medical Doctor | The Affiliated Hospital Of Guizhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550002 | China |
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| Adalimumab | Drug | The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg,q4w,subcutaneous injection. |
|
| week 104 |
| Spondyloarthritis Research Consortium of Canada (SPARCC) | The SPARCC assessment method is a valuable tool in the field of spondyloarthritis research and diagnosis. The assessment Items include:
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. | week 104 |
| week 12, week 24, week 52 |
| Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6) | Proportion of subjects achieving ASAS5/6 at week 12, week 24, week 52. A patient is considered an ASAS5/6 responder if they achieve at least a 20% improvement in at least five of the six items mentioned below:
| week 12, week 24, week 52 |
| Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR) | Proportion of subjects achieving ASAS PR at week 12, week 24, week 52 (The absolute score for each of the 4 indicators identified in ASAS 40 ≤ 2 units) | week 12, week 24, week 52 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 | Proportion of subjects achieving BASDAI 50 at week 12, week 24, week 52. BASDAI50 is defined as a patient who has at least a 50% improvement from baseline in BASDAI score over the course of treatment. Assessment Domains (each scale from 0 to 10, the higher the score, the more severe the symptom):
Scoring Calculation: The scores of the five aspects above are added together, resulting in a total score ranging from 0 to 50. This total score is then divided by 5 to obtain the final BASDAI score, which ranges from 0 to 10. | week 12, week 24, week 52 |
| BASDAI | Change from baseline in BASDAI score at week 12, week 24, week 52. Assessment Domains (each scale from 0 to 10, the higher the score, the more severe the symptom):
Scoring Calculation: The scores of the five aspects above are added together, resulting in a total score ranging from 0 to 50. This total score is then divided by 5 to obtain the final BASDAI score, which ranges from | week 12, week 24, week 52 |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | Change from baseline in BASFI score. The BASFI assesses a patient's ability to perform 10 daily activities. These include things like bending to pick up an object from the floor, getting in and out of a car, and turning around in bed. Scoring Process
The lower the score, the lower the disease activity. | week 12, week 24, week 52 |
| Visual Analogue Scale (VAS) | Change from baseline in VAS score. The VAS (Visual Analogue Scale) scoring method is a commonly used tool for quantitative assessment in medicine that allows patients to directly mark their perceived degree of a certain symptom or condition on a straight line. It transforms subjective feelings into objective numerical values for quantification and comparison. Scoring Process: a 10-cm straight line is used, with the left end marked as 0 representing no symptom or the best condition, and the right end marked as 10 representing the most severe symptom or the worst condition. | week 12, week 24, week 52 |
| Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is used to evaluate enthesitis in patients with ankylosing spondylitis. Evaluation Sites:The MASES assesses 13 enthesis sites, namely the left and right first costochondral joints, the left and right seventh costochondral joints, the left and right posterior superior iliac spines, the left and right anterior superior iliac spines, the left and right iliac crests, the proximal insertions of the left and right Achilles tendons, and the fifth lumbar spinous process. Scoring Criteria:Absence of pain at the enthesis site is scored as 0, and presence of pain is scored as 1. The total score is the sum of the scores of all sites, ranging from 0 to 13. | week 12, week 24, week 52 |
| tender joint count (TJC), swollen joint count(SJC) | Change from baseline in 44 TJC and 44 TJC | week 12, week 24, week 52 |
| Ankylosing Spondylitis Disease Activity Score based on C-reactive Protein (ASDAS-CRP) | Change from baseline in ASDAS-CRP. Components of Assessment: 1)Patient Global Assessment : Patients rate their overall disease activity in the past week on a 0 - 100 mm Visual Analogue Scale, with 0 indicating no disease activity and 100 representing the most severe activity.2)Spinal Pain: The patient assesses the pain in the spine in the past week on a 0 - 100 mm VAS, where 0 means no pain and 100 is the most intense pain.3) Inflammatory Back Pain: It is scored based on a binary scale, 0 for no pain.4)C-reactive Protein level. Calculation of the Score: The ASDAS-CRP score is calculated through a specific formula: ASDAS-CRP = 0.12 × PGA + 0.28 × spinal pain + 0.16 × IBP + 0.10 × ln(CRP + 1). The result of the calculation is the ASDAS-CRP score, which is used to classify the disease activity level. Generally, a score of <1.3 indicates inactive disease, 1.3 - 2.1 indicates low disease activity, 2.1 - 3.5 indicates moderate disease activity, and >3.5 indicates high disease activity. | week 12, week 24, week 52 |
| Ankylosing Spondylitis Disease Activity Score based on Erythrocyte Sedimentation Rate (ASDAS-ESR) | Change from baseline in ASDAS-ESR. Assessment Elements: 1)Patient Global Assessment: Similar to ASDAS-CRP, patients rate their overall disease activity in the past week on a 0 - 100 mm Visual Analogue Scale (VAS), with 0 meaning no disease activity and 100 being the highest level of activity.2)Spinal Pain: Patients assess their spinal pain in the past week on a 0 - 100 mm VAS, where 0 represents no pain and 100 is the worst pain.3)Inflammatory Back Pain (IBP): It is scored as 0 for no IBP and 1 for having IBP.4)Erythrocyte Sedimentation Rate (ESR): The ESR value in mm/h is used as a key indicator. Score Calculation:The formula for calculating ASDAS-ESR is: ASDAS-ESR = 0.12 × PGA + 0.28 × spinal pain + 0.16 × IBP + 0.08 × ln(ESR + 1). The calculated score is used to determine the disease activity level. Typically, a score of <1.3 suggests inactive disease, 1.3 - 2.1 indicates low disease activity, 2.1 - 3.5 represents moderate disease activity, and >3.5 means high disease activity. | week 12, week 24, week 52 |
| Ankylosing Spondylitis Quality of Life (ASQoL) | Change from baseline in ASQoL. The ASQoL questionnaire consists of 19 questions covering various aspects such as pain, physical function, mental state, and social life. For example, questions about the impact of the disease on daily activities like dressing, walking, and climbing stairs; how the disease affects mood, sleep, and relationships with others. Scoring Method: Each question is scored on a 5-point scale, usually from 0 to 4, with 0 indicating no impact on quality of life and 4 indicating a very severe impact. The scores of all questions are summed up. The total score ranges from 0 to 76. A higher score indicates a poorer quality of life. | week 12, week 24, week 52 |
| Adverse event (AE) | Incidence of adverse events | week 12, week 24, week 52,week 104 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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