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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04875299
Other study ID # ADL-TDM-02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
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