Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875299
• Other study ID #: ADL-TDM-02
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: May 2023

Study information

• Verified date: August 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Liyan Miao, Ph.D
• Phone: (86) 512 67972858
• Email: miaolysuzhou[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• The study is observational
The study is observational

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (12)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Soochow University

Affiliated Hospital of Nantong University, Central South University, First Affiliated Hospital of Chongqing Medical University, Liaocheng People's Hospital, Qingdao Municipal Hospital, Shandong Provincial Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, the first affiliated hospital of Liaoning university of traditional Chinese medicine, The First People's Hospital of Changzhou, Tianjin First Central Hospital, Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in ASDAS	ASDAS will be measured at week 24 and will be compared to baseline	Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ASDAS remission	ASDAS < 2.1 at assessment time point is considered as remission	Week 2, 4, 8, 12, 24
Secondary	Safety analysis - Occurence of adverse event	Safety analysis include occurence of adverse event	Week 24