Trials / Unknown
UnknownNCT04875299
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 480 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | The study is observational | The study is observational |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2023-01-01
- Completion
- 2023-05-01
- First posted
- 2021-05-06
- Last updated
- 2021-08-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04875299. Inclusion in this directory is not an endorsement.