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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Details and patient eligibility
About
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
Full 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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
452 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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