Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

NCT ID: NCT00544557

Last Updated: 2015-05-12

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

1715 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2014-05-31

Brief Summary

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This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.

Detailed Description

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Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Ankylosing Spondylitis

Etanercept

Intervention Type DRUG

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

Interventions

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Etanercept

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

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ankylosing spondylitis (AS)

Exclusion Criteria

* Hypersensitivity to etanercept
* Active infection including chronic or localised infection
* Sepsis or risk of sepsis
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

Locations

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Klinikum Benjamin Franklin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Druce KL, Aikman L, Dilleen M, Burden A, Szczypa P, Basu N. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29;20(1):96. doi: 10.1186/s13075-018-1598-8.

Reference Type DERIVED
PMID: 29843776 (View on PubMed)

Related Links

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Other Identifiers

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B1801087

Identifier Type: OTHER

Identifier Source: secondary_id

0881X1-4463

Identifier Type: -

Identifier Source: org_study_id

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