Clinical trial NCT03505892: A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
Official title: A Real-world, Prospective, Observational Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis (AS)
Keywords: Ankylosing Spondylitis (AS)
Adaliumumab
Humira
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Ankylosing Spondylitis (AS) after the initiation of adalimumab therapy in the real-world practices in Taiwan.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
timeFrame: 24 Weeks after initiation of Humira therapy
Secondary outcomes:
measure: Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24
timeFrame: 24 Weeks after initiation of Humira therapy
measure: Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24
timeFrame: 24 Weeks after initiation of Humira therapy
measure: Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Percentages of participants whose disease activity states are inactive per ASDAS score
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Percentages of participants whose disease activity states are moderate per ASDAS score
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Changes of the frequency of overall extra-articular manifestations (EAM) of interest
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Changes of the respective frequency of each EAM
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Change in Tender Joint Counts (TJC)
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
measure: Change in Swollen Joint Counts (SJC)
timeFrame: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: