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Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (IDEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01754727
First received: December 19, 2012
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.

Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 452
Study Start Date: December 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754727

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Liliana Iosub AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01754727     History of Changes
Other Study ID Numbers: P13-682
Study First Received: December 19, 2012
Results First Received: October 26, 2016
Last Updated: January 17, 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

ClinicalTrials.gov processed this record on August 17, 2017