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.
Study Type
OBSERVATIONAL
Enrollment
28
Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
Hualien City, Taiwan
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.
Time frame: 24 Weeks after initiation of Humira therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)