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| Name | Class |
|---|---|
| Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Central South University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.
This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adalimumab TDM | Patients with active ankylosing spondylitis receiving adalimumab treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The study is observational | Other | The study is observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in ASDAS | ASDAS will be measured at week 24 and will be compared to baseline | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ASAS20 response | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. |
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Inclusion Criteria:
Exclusion Criteria:
(1) Hepatitis B or tuberculosis patients
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This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyan Miao, Ph.D | Contact | (86) 512 67972858 | miaolysuzhou@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, Ph.D | The Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Tianjin First Central Hospital | OTHER |
| Wuxi No. 2 People's Hospital | OTHER |
| The First People's Hospital of Changzhou | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Qingdao Municipal Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
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plasma and DNA
| Week 2, 4, 8, 12, 24 |
| ASAS40 response | ASAS 40 = 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. | Week 2, 4, 8, 12, 24 |
| BASDAI50 response | Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI. | Week 2, 4, 8, 12, 24 |
| ASDAS response | A decrease in ASDAS from baseline (△ASDAS) ≥ 2.0 or a moderate disease activity achievement (ASDAS < 2.1) with △ASDAS ≥ 1.1 is considered as response | Week 2, 4, 8, 12, 24 |
| ASDAS remission | ASDAS < 2.1 at assessment time point is considered as remission | Week 2, 4, 8, 12, 24 |
| Safety analysis - Occurence of adverse event | Safety analysis include occurence of adverse event | Week 24 |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |