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

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

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 Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis (AS)

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan, 970
    • Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants with Ankylosing Spondylitis (AS) after the initiation of adalimumab therapy in the real-world practices in Taiwan.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants receiving adalimumab; Participants with AS receiving adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Humira; Ankylosing Spondylitis (AS); Adaliumumab
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: P16-326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No