Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

NCT ID: NCT01188655

Last Updated: 2011-09-12

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

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

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This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

Detailed Description

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The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

Conditions

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Spondylitis, Ankylosing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group Enbrel

Enbrel

Intervention Type DRUG

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Interventions

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Enbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Intervention Type DRUG

Other Intervention Names

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etanercept

Eligibility Criteria

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Inclusion Criteria

* Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
* Patients treated as an outpatient

Exclusion Criteria

* Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
* Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
* Patients with sepsis or risk of sepsis should not be treated.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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B1801095

Identifier Type: -

Identifier Source: secondary_id

0881X1-4456

Identifier Type: -

Identifier Source: org_study_id

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