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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.

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Detailed Description

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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).

Conditions

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Ankylosing Spondylitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Ankylosing Spondylitis (AS)

Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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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