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

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ClinicalTrials.gov Identifier: NCT03505892
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Ankylosing Spondylitis (AS)

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Study Type : Observational
Estimated Enrollment : 140 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 : June 5, 2018
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : March 14, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Participants receiving adalimumab
Participants with AS receiving adalimumab



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505892


Contacts
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Contact: Ellen Cheng 886225039818 ellen.cheng@abbvie.com
Contact: YY Yeh yuhying.yeh@abbvie.com

Locations
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Taiwan
Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation Recruiting
Hualien City, Taiwan, 970
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03505892     History of Changes
Other Study ID Numbers: P16-326
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by AbbVie:
Ankylosing Spondylitis (AS)
Adalimumab
Humira

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents