Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis, adalimumab
Brief summary
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.
Detailed description
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).
Interventions
The study is observational
Sponsors
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Central South University
First Affiliated Hospital of Chongqing Medical University
Tianjin First Central Hospital
Wuxi No. 2 People's Hospital
The First People's Hospital of Changzhou
Affiliated Hospital of Nantong University
Shandong Provincial Hospital
Qingdao Municipal Hospital
Liaocheng People's Hospital
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
The First Affiliated Hospital of Soochow University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consent of the patient. 2. Patient who meets the definition of Ankylosing Spondylitis based on the 1984 Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis (BASDAI ≥ 4, Back pain ≥ 4). 3. Patients who have indication of adalimumab. 4. Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks.
Exclusion criteria
(1) Hepatitis B or tuberculosis patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in ASDAS | Week 24 | ASDAS will be measured at week 24 and will be compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASAS40 response | Week 2, 4, 8, 12, 24 | 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. |
| BASDAI50 response | Week 2, 4, 8, 12, 24 | 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. |
| ASAS20 response | Week 2, 4, 8, 12, 24 | 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. |
| ASDAS remission | Week 2, 4, 8, 12, 24 | ASDAS \< 2.1 at assessment time point is considered as remission |
| Safety analysis - Occurence of adverse event | Week 24 | Safety analysis include occurence of adverse event |
| ASDAS response | Week 2, 4, 8, 12, 24 | 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 |
Countries
China
Contacts
Primary ContactLiyan Miao, Ph.D
Outcome results
None listed