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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT03505892

Collaborator

(none)

Enrollment

Location

40.7

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis (AS)

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 5, 2018

Actual Primary Completion Date :

Oct 25, 2021

Actual Study Completion Date :

Oct 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving adalimumab Participants with AS receiving adalimumab

Outcome Measures

Primary Outcome Measures

Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 [24 Weeks after initiation of Humira therapy]
This accounts for participants achieving 50% improvement in BASDAI.

Secondary Outcome Measures

Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24 [24 Weeks after initiation of Humira therapy]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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)]
This accounts for participants achieving 50% improvement in BASDAI.
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)]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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)]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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)]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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)]
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
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)]
The change of the frequency of overall extra-articular manifestations (EAM) will be assessed.
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)]
The changes of the respective frequency of each EAM will be assessed.
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)]
The change in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon will be assessed.
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)]
The change in MASES score will be assessed.
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)]
The change of TJC (0-46), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed.
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)]
The change of SJC (0-44), in participants who had peripheral arthritis (≥1 swollen joint) at baseline will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.