Status:
UNKNOWN
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Central South University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
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 relationshi...
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 Anky...
Eligibility Criteria
Inclusion
- 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
- (1) Hepatitis B or tuberculosis patients
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04875299
Start Date
September 1 2021
End Date
May 1 2023
Last Update
August 25 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000