Clinical trial NCT00410046: Extension Study Evaluating Etanercept in Ankylosing Spondylitis
Official title: An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
timeFrame: 96 weeks
measure: Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
timeFrame: 96 weeks
Secondary outcomes:
measure: Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
timeFrame: 48 weeks
measure: Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
timeFrame: 48 weeks
measure: Number of Patients With Sick Leave During 48 Weeks Treatment
timeFrame: 48 weeks
measure: Number of Sick Days Per Patient During the 48 Weeks of Treatment
timeFrame: 48 weeks
measure: Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change in Total Back Pain Score From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
timeFrame: Baseline and 38 weeks
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
timeFrame: Baseline and 38 weeks
measure: Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
timeFrame: Baseline and 38 weeks
Other outcomes:
Locations:
city: Fredriksberg
country: Denmark
city: Odense
country: Denmark
city: Svendborg
country: Denmark
city: Vejle
country: Denmark
city: Helsinki
country: Finland
city: Hyvinkaa
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Stockholm
country: Sweden
city: Basingstoke
country: United Kingdom
city: Bath
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: Wyeth Reserach
name: Medical Monitor
role: STUDY_DIRECTOR
References: