Clinical trial NCT01754727: Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Effectiveness
Post-marketing observational study (PMOS)
Adalimumab
Humira®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
timeFrame: Month 0 (baseline) and Month 12
Secondary outcomes:
measure: Percentage of Participants Achieving BASDAI 50
timeFrame: Month 3, Month 6 and Month 9
measure: Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Mean Change in the Number of Hospital Inpatient Days
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Mean Change in the Number of Hospitalizations
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Mean Change in the Number of Sick Leave Days
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Mean Change in the Number of Sick Leaves
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Mean Change From Baseline in BASDAI Score
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)
measure: Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Liliana Iosub
role: STUDY_DIRECTOR
References: