Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

Soochow University

Status and phase: Unknown; Phase 1

Conditions: Ankylosing Spondylitis

Treatments: Other: The study is observational

Study type: Observational

Funder types: Other

Identifiers

NCT04875299

ADL-TDM-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

480 participants in 1 patient group

adalimumab TDM

Description:

Patients with active ankylosing spondylitis receiving adalimumab treatment.

Treatment:

Other: The study is observational