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 TreatmentNumber 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 TreatmentNumber 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
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