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Completed

NCT Number: NCT03505892

A 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.

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Key information

Conditions

Ankylosing Spondylitis (AS) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation

Hualien City, 970, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24

    Time frame: 24 Weeks after initiation of Humira therapy

    The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.

  2. Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24

    Time frame: 24 Weeks after initiation of Humira therapy

    The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.

  3. Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)

    This accounts for participants achieving 50% improvement in BASDAI.

  4. Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 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.

  5. Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 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.

  6. Percentages of participants whose disease activity states are inactive per ASDAS score

    Time frame: 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.

  7. Percentages of participants whose disease activity states are moderate per ASDAS score

    Time frame: 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.

  8. Changes of the frequency of overall extra-articular manifestations (EAM) of interest

    Time frame: 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.

  9. Changes of the respective frequency of each EAM

    Time frame: 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.

  10. Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon

    Time frame: 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.

  11. Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    Time frame: 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.

  12. Change in Tender Joint Counts (TJC)

    Time frame: 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.

  13. Change in Swollen Joint Counts (SJC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: EAST

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2018
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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