Ankylosing Spondylitis (AS)EASTNCT03505892
A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
An observational study of Ankylosing Spondylitis (AS), run by AbbVie at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis (AS)
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2018to 25 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Ankylosing Spondylitis (AS) after the initiation of adalimumab therapy in the real-world practices in Taiwan.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
Hualien City, 970
About this study
Official title: 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.
- Conditions
- Ankylosing Spondylitis (AS)
- Keywords
- Ankylosing Spondylitis (AS), Adaliumumab, Humira
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving adalimumab | Participants with AS receiving adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start5 Jun 2018
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505892
- Sponsor's protocol ID
- P16-326
- Acronym
- EAST
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Prospective, Observational Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
- ClinicalTrials.gov ID
- NCT03505892
- Acronym / sponsor ID
- EAST / P16-326
- Conditions
- Ankylosing Spondylitis (AS)
- Keywords
- Ankylosing Spondylitis (AS), Adaliumumab, Humira
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving adalimumab | – | –Participants with AS receiving adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Ankylosing Spondylitis (AS) after the initiation of adalimumab therapy in the real-world practices in Taiwan.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
13 secondary outcomes
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis (AS), run by AbbVie at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.