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

NCT03505892 | Completed

• 1 other identifier: P16-326
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis (AS)

Keywords

Ankylosing Spondylitis (AS); Adaliumumab; Humira

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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) at Week 24

  24 Weeks after initiation of Humira therapy

• 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 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)

Study Arms (1)

Participants receiving adalimumab

Participants with AS receiving adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation

Hualien City, 970, Taiwan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 23, 2018
• Study Start: June 5, 2018
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

TW (1)