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

AbbVie1 site in 1 country28 target enrollmentJune 5, 2018

ConditionsAnkylosing Spondylitis (AS)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ankylosing Spondylitis (AS)
Sponsor: AbbVie
Enrollment: 28
Locations: 1
Primary Endpoint: Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 5, 2018

End Date

October 25, 2021

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24

Time Frame: 24 Weeks after initiation of Humira therapy

This accounts for participants achieving 50% improvement in BASDAI.

Secondary Outcomes

Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24(24 Weeks after initiation of Humira therapy)
Changes of the frequency of overall extra-articular manifestations (EAM) of interest(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)(At Week 0 (Baseline) and 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) at Week 24(24 Weeks after initiation of Humira therapy)
Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)(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)(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(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(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(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(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(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)(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)(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))