Extension Study Evaluating Etanercept in Ankylosing Spondylitis

NCT ID: NCT00410046

Last Updated: 2012-05-11

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

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-10-31

Brief Summary

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The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.

Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept (ETN)

Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Group Type EXPERIMENTAL

Enbrel (etanercept)

Intervention Type DRUG

Etanercept 50 mg SC injection once weekly

Interventions

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Enbrel (etanercept)

Etanercept 50 mg SC injection once weekly

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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Inclusion Criteria

* Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Exclusion Criteria

* Withdrawal from the ASCEND study for safety or any other reason.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth Reserach

Locations

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Fredriksberg, , Denmark

Site Status

Odense, , Denmark

Site Status

Svendborg, , Denmark

Site Status

Vejle, , Denmark

Site Status

Helsinki, , Finland

Site Status

Hyvinkää, , Finland

Site Status

Kuopio, , Finland

Site Status

Tampere, , Finland

Site Status

Stockholm, , Sweden

Site Status

Basingstoke, , United Kingdom

Site Status

Bath, , United Kingdom

Site Status

Cambridge, , United Kingdom

Site Status

Cannock, , United Kingdom

Site Status

Liverpool, , United Kingdom

Site Status

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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Denmark Finland Sweden United Kingdom

References

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Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.

Reference Type DERIVED
PMID: 38488976 (View on PubMed)

Other Identifiers

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0881A3-405

Identifier Type: -

Identifier Source: org_study_id

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