Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

The First Affiliated Hospital of Soochow University480 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

480

Conditions

Ankylosing Spondylitis

Interventions

The study is observationalOTHER

The study is observational

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

Mean Change From Baseline in ASDAS

ASDAS will be measured at week 24 and will be compared to baseline

Time frame: Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Week 2, 4, 8, 12, 24

ASDAS remission

ASDAS \< 2.1 at assessment time point is considered as remission

Central Contacts

Liyan Miao, Ph.D

CONTACT

(86) 512 67972858 miaolysuzhou@163.com

Data from ClinicalTrials.gov

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