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Ankylosing SpondylitisNCT04875299

Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

An observational study of Ankylosing Spondylitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
The study is observational
How many people
480 participants
Where
1 siteChina
Study dates
Sep 2021to May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Hepatitis B or tuberculosis patients

Trial locations and contacts

1 site in 1 country.

Liyan Miao, Ph.D contact

(86) 512 67972858

miaolysuzhou@163.com

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

    Liyan Miao, Ph.D, (86) 512 67972858, miaolysuzhou@163.com

    Liyan Miao, Ph.D

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
The study is observational
Keywords
Ankylosing Spondylitis, adalimumab
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The study is observationalOther

    The study is observational

Study groups in NCT04875299
Study groupRoleWhat they receive
adalimumab TDMPatients with active ankylosing spondylitis receiving adalimumab treatment.
Receives: Other: The study is observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in ASDAS

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

    Measured: Week 24

Secondary outcomes (6)

  1. 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.

    Measured: Week 2, 4, 8, 12, 24

  2. 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.

    Measured: Week 2, 4, 8, 12, 24

  3. 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.

    Measured: Week 2, 4, 8, 12, 24

  4. 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

    Measured: Week 2, 4, 8, 12, 24

  5. ASDAS remission

    ASDAS < 2.1 at assessment time point is considered as remission

    Measured: Week 2, 4, 8, 12, 24

  6. Safety analysis - Occurence of adverse event

    Safety analysis include occurence of adverse event

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875299
Sponsor's protocol ID
ADL-TDM-02
Status last verified
Aug 2021
First submitted
29 Apr 2021
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ding X, Xue L, Wang M, Pan S, Zhang B, Li F, Ma Y, Hu N, He D, Song L, Jiang S, Zhu S, Wu J, Miao L. Longitudinal monitoring of adalimumab levels and anti-adalimumab antibodies in Chinese patients with ankylosing spondylitis: a prospective cohort study. Front Immunol. 2026 Oct 1;17:1893483. doi: 10.3389/fimmu.2026.1893483. eCollection 2026.

    PubMed 42889219

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liyan Miao, Ph.D ((86) 512 67972858, miaolysuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in ASDAS (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.

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