Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (IDEA)
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ClinicalTrials.gov Identifier: NCT01754727 |
Recruitment Status
:
Completed
First Posted
: December 21, 2012
Results First Posted
: March 6, 2017
Last Update Posted
: March 6, 2017
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Condition or disease |
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Ankylosing Spondylitis |
Study Type : | Observational |
Actual Enrollment : | 452 participants |
Time Perspective: | Prospective |
Official Title: | Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2015 |

Group/Cohort |
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Participants with Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
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- 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.
- Percentage of Participants Achieving BASDAI 50 [ Time Frame: Month 3, Month 6 and Month 9 ]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.
- 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 ]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.
- 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 ]Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
- Mean Change in the Number of Hospitalizations [ Time Frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12 ]Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
- 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 ]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)
- Mean Change in the Number of Sick Leaves [ Time Frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12 ]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).
- 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 ]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.
- 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) ]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).
- Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score [ Time Frame: Month 3, Month 6, Month 9 and Month 12 ]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.
- Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score [ Time Frame: Month 3, Month 6, Month 9 and Month 12 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Had contraindications for the treatment with adalimumab

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): NCT01754727
Study Director: | Liliana Iosub | AbbVie |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01754727 History of Changes |
Other Study ID Numbers: |
P13-682 |
First Posted: | December 21, 2012 Key Record Dates |
Results First Posted: | March 6, 2017 |
Last Update Posted: | March 6, 2017 |
Last Verified: | January 2017 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Ankylosing Spondylitis Effectiveness Post-marketing observational study (PMOS) Adalimumab Humira® |
Additional relevant MeSH terms:
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 |