N/A
Completed N=452
Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
Source: ClinicalTrials.gov NCT01754727 ↗Enrolled (actual)
452
Serious AEs
4.2%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12 — 78.9 percentage of participants
Summary
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12 |
78.9 | — |
| SECONDARY Percentage of Participants Achieving BASDAI 50 |
52.5; 68.1; 76.0 | — |
| SECONDARY Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline |
44.3; 54.5; 63.5; 64.8 | — |
| SECONDARY Mean Change in the Number of Hospital Inpatient Days |
-19.6 | — |
| SECONDARY Mean Change in the Number of Hospitalizations |
-1.9 | — |
| SECONDARY Mean Change in the Number of Sick Leave Days |
-27.3 | — |
| SECONDARY Mean Change in the Number of Sick Leaves |
-2.1 | — |
| SECONDARY Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider |
-12.1; -4.3; -4.4; -1.1; -0.6; -0.4 | — |
| SECONDARY Mean Change From Baseline in BASDAI Score |
-3.1; -3.8; -4.3; -4.4; -4.0 | — |
| SECONDARY Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score |
-1.8; -2.1; -2.3; -2.4; -2.2 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score |
-2.7; -3.5; -3.8; -4.0; -3.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01754727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.