Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Other: The study is observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent of the patient. 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). Patients who have indication of adalimumab. Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks. Exclusion Criteria: (1) Hepatitis B or tuberculosis patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adalimumab TDM<br>Patients with active ankylosing spondylitis receiving adalimumab treatment. | Other: The study is observational<br>* The study is observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing Spondylitis, adalimumab