Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Other: The study is observational

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 Ankylosing Spondylitis Disease Activity Score (ASDAS).

• Study Type: Observational
• Enrollment (Anticipated): 480

Contacts and Locations

• Study Contact: Name: Liyan Miao, Ph.D; Phone Number: (86) 512 67972858; Email: miaolysuzhou@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital Of Soochow University
      • Contact: Liyan Miao, Ph.D; Phone Number: (86) 512 67972858; Email: miaolysuzhou@163.com
      • Principal Investigator: Liyan Miao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adalimumab TDM; Patients with active ankylosing spondylitis receiving adalimumab treatment.	Other: The study is observational; The study is observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in ASDAS	ASDAS will be measured at week 24 and will be compared to baseline	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
ASDAS remission	ASDAS < 2.1 at assessment time point is considered as remission	Week 2, 4, 8, 12, 24
Safety analysis - Occurence of adverse event	Safety analysis include occurence of adverse event	Week 24

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Shandong Provincial Hospital; Qingdao Municipal Hospital; Central South University; Tianjin First Central Hospital; First Affiliated Hospital of Chongqing Medical University; The First People's Hospital of Changzhou; Liaocheng People's Hospital; Affiliated Hospital of Nantong University; Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Wuxi No. 2 People's Hospital
• Investigators: Study Chair: Liyan Miao, Ph.D, The Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: adalimumab; Ankylosing Spondylitis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: ADL-TDM-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No