A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)

Study Overview
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Brief Summary
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The objectives of this prospective observational study is to explore 1-year clinical response via both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) after initiation of adalimumab therapy in AS patients from routine clinical practices in Taiwan.

Official Title
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A Real-world, Prospective, Observational Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)

Conditions
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Ankylosing Spondylitis (AS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with confirmed AS. Participant will start adalimumab as treatment Participant must provide the written authorization form and agree to provide personal and/or health data prior to the entry into the study. Exclusion Criteria: Participant has been treated with any investigational drug or biologic within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit. Participants who fulfill any of the contraindications as per Humira label in Taiwan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving adalimumab<br>Participants with AS receiving adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | This accounts for participants achieving 50% improvement in BASDAI. | 24 Weeks after initiation of Humira therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24 | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | 24 Weeks after initiation of Humira therapy | 
| Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24 | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | 24 Weeks after initiation of Humira therapy | 
| Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | This accounts for participants achieving 50% improvement in BASDAI. | Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Percentages of participants whose disease activity states are inactive per ASDAS score | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Percentages of participants whose disease activity states are moderate per ASDAS score | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Changes of the frequency of overall extra-articular manifestations (EAM) of interest | The change of the frequency of overall extra-articular manifestations (EAM) will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Changes of the respective frequency of each EAM | The changes of the respective frequency of each EAM will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon | The change in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | The change in MASES score will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Change in Tender Joint Counts (TJC) | The change of TJC (0-46), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 
| Change in Swollen Joint Counts (SJC) | The change of SJC (0-44), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed. | At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing Spondylitis (AS), Adaliumumab, Humira