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Extension Study Evaluating Etanercept in Ankylosing Spondylitis

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Enbrel (etanercept) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth Reserach

Summary

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.

Clinical Details

Official title: An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment

Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment

Secondary outcome:

Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment

Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment

Number of Patients With Sick Leave During 48 Weeks Treatment

Number of Sick Days Per Patient During the 48 Weeks of Treatment

Change in Patient Global Assessment of Disease Activity From Baseline to Week 38

Change in Total Back Pain Score From Baseline to Week 38

Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38

Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38

Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38

Change From Baseline Haywood Quality of Life Score From Baseline to Week 38

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Fredriksberg DK-2000, Denmark

Odense DK-5000, Denmark

Svendborg DK-5700, Denmark

Vejle DK-7100, Denmark

Helsinki FIN-130, Finland

Hyvinkaa FIN-05800, Finland

Kuopio FIN-70211, Finland

Tampere FIN-33100, Finland

Stockholm SE-17176, Sweden

Basingstoke RG249NA, United Kingdom

Bath BA11RL, United Kingdom

Cambridge CB22QQ, United Kingdom

Cannock WS112XY, United Kingdom

Liverpool L97AL, United Kingdom

Newcastle upon Tyne NE77DN, United Kingdom

Wirral CH495PE, United Kingdom

Additional Information

Starting date: December 2006
Last updated: April 9, 2012

Page last updated: August 23, 2015

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