Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

NCT04875299 | Unknown

• 1 other identifier: ADL-TDM-02
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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 relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; adalimumab

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in ASDAS

  ASDAS will be measured at week 24 and will be compared to baseline

  Week 24

Secondary Outcomes (6)

• ASAS20 response

  Week 2, 4, 8, 12, 24

• ASAS40 response

  Week 2, 4, 8, 12, 24

• BASDAI50 response

  Week 2, 4, 8, 12, 24

• ASDAS response

  Week 2, 4, 8, 12, 24

• ASDAS remission

  Week 2, 4, 8, 12, 24

Study Arms (1)

adalimumab TDM

Patients with active ankylosing spondylitis receiving adalimumab treatment.

Other: The study is observational

Interventions

The study is observational OTHER

The study is observational

adalimumab TDM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment.

You may qualify if:

• 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.

You may not qualify if:

• (1) Hepatitis B or tuberculosis patients

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Central South University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Tianjin First Central Hospital: collaborator
• Wuxi No. 2 People's Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Shandong Provincial Hospital: collaborator
• Qingdao Municipal Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and DNA

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Liyan Miao, Ph.D

  The Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Liyan Miao, Ph.D

CONTACT

(86) 512 67972858; miaolysuzhou@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)