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

Ankylosing Spondylitis (AS) Clinical Trial

— EAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505892
• Other study ID #: P16-326
• Status: Completed
• Start date: June 5, 2018
• Est. completion date: October 25, 2021

Study information

• Verified date: July 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Taiwan	Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   clinical study report synopsis