Ankylosing Spondylitis Clinical Trial
Official title:
Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study
NCT number | NCT04875299 |
Other study ID # | ADL-TDM-02 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2021 |
Est. completion date | May 2023 |
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.
Status | Not yet recruiting |
Enrollment | 480 |
Est. completion date | May 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University | Affiliated Hospital of Nantong University, Central South University, First Affiliated Hospital of Chongqing Medical University, Liaocheng People's Hospital, Qingdao Municipal Hospital, Shandong Provincial Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, the first affiliated hospital of Liaoning university of traditional Chinese medicine, The First People's Hospital of Changzhou, Tianjin First Central Hospital, Wuxi No. 2 People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in ASDAS | ASDAS will be measured at week 24 and will be compared to baseline | Week 24 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | ASDAS remission | ASDAS < 2.1 at assessment time point is considered as remission | Week 2, 4, 8, 12, 24 | |
Secondary | Safety analysis - Occurence of adverse event | Safety analysis include occurence of adverse event | Week 24 |
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