Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

NCT ID: NCT04875299

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adalimumab TDM

Patients with active ankylosing spondylitis receiving adalimumab treatment.

The study is observational

Intervention Type OTHER

The study is observational

Interventions

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The study is observational

The study is observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Tianjin First Central Hospital

OTHER

Sponsor Role collaborator

Wuxi No. 2 People's Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Qingdao Municipal Hospital

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Miao Liyan

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liyan Miao, Ph.D

Role: STUDY_CHAIR

The Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Liyan Miao, Ph.D

Role: CONTACT

(86) 512 67972858

Facility Contacts

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Liyan Miao, Ph.D

Role: primary

(86) 512 67972858

Other Identifiers

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ADL-TDM-02

Identifier Type: -

Identifier Source: org_study_id

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