Ankylosing SpondylitisIDEANCT01754727
Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott).
Trial summary
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Study population consisted of participants with ankylosing spondylitis (AS) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.
Who may be able to join
- Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
- Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment
- Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines
- Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Who cannot join
- Had contraindications for the treatment with adalimumab
About this study
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
Read the detailed description
This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Effectiveness, Post-marketing observational study (PMOS), Adalimumab, 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 with Ankylosing Spondylitis (AS) | Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.
Measured: Month 0 (baseline) and Month 12
Secondary outcomes (10)
Percentage of Participants Achieving BASDAI 50
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.
Measured: Month 3, Month 6 and Month 9
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.
Measured: Month 3, Month 6, Month 9 and Month 12
Mean Change in the Number of Hospital Inpatient Days
Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Hospitalizations
Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Sick Leave Days
Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Sick Leaves
Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider
Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change From Baseline in BASDAI Score
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.
Measured: Month 3, Month 6, Month 9 and Month 12
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.
Measured: Month 3, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liliana Iosub, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754727
- Sponsor's protocol ID
- P13-682
- Acronym
- IDEA
- Status last verified
- Jan 2017
- First submitted
- 19 Dec 2012
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
- ClinicalTrials.gov ID
- NCT01754727
- Acronym / sponsor ID
- IDEA / P13-682
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Effectiveness, Post-marketing observational study (PMOS), Adalimumab, Humira®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
Detailed description
This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Ankylosing Spondylitis (AS) | – | –Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consisted of participants with ankylosing spondylitis (AS) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.
Key inclusion criteria (4 listed)
- Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
- Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment
- Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines
- Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Key exclusion criteria (1 listed)
- Had contraindications for the treatment with adalimumab
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 Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
Time frame: Month 0 (baseline) and Month 12
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.
10 secondary outcomes
Percentage of Participants Achieving BASDAI 50
Time frame: Month 3, Month 6 and Month 9
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline
Time frame: Month 3, Month 6, Month 9 and Month 12
Mean Change in the Number of Hospital Inpatient Days
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Hospitalizations
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Sick Leave Days
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Sick Leaves
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Mean Change From Baseline in BASDAI Score
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score
Time frame: Month 3, Month 6, Month 9 and Month 12
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: Month 3, Month 6, Month 9 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Liliana Iosub study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott).
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 4 inclusion and 1 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12 (time frame: Month 0 (baseline) and Month 12). 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 6 Mar 2017.