Extension Study Evaluating Etanercept in Ankylosing Spondylitis
An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
1 other identifier
interventional
84
4 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2006
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 8, 2006
CompletedFirst Posted
Study publicly available on registry
December 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
May 11, 2012
CompletedMay 11, 2012
April 1, 2012
1.8 years
December 8, 2006
October 30, 2009
April 9, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
96 weeks
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
96 weeks
Secondary Outcomes (12)
Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
48 weeks
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
48 weeks
Number of Patients With Sick Leave During 48 Weeks Treatment
48 weeks
Number of Sick Days Per Patient During the 48 Weeks of Treatment
48 weeks
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Baseline and 38 weeks
- +7 more secondary outcomes
Study Arms (1)
Etanercept (ETN)
EXPERIMENTALPatients 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.
Interventions
Etanercept 50 mg SC injection once weekly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Withdrawal from the ASCEND study for safety or any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Fredriksberg, DK-2000, Denmark
Unknown Facility
Odense, DK-5000, Denmark
Unknown Facility
Svendborg, DK-5700, Denmark
Unknown Facility
Vejle, DK-7100, Denmark
Unknown Facility
Helsinki, FIN-130, Finland
Unknown Facility
Hyvinkää, FIN-05800, Finland
Unknown Facility
Kuopio, FIN-70211, Finland
Unknown Facility
Tampere, FIN-33100, Finland
Unknown Facility
Stockholm, SE-17176, Sweden
Unknown Facility
Basingstoke, RG249NA, United Kingdom
Unknown Facility
Bath, BA11RL, United Kingdom
Unknown Facility
Cambridge, CB22QQ, United Kingdom
Unknown Facility
Cannock, WS112XY, United Kingdom
Unknown Facility
Liverpool, L97AL, United Kingdom
Unknown Facility
Metropolitan Borough of Wirral, CH495PE, United Kingdom
Unknown Facility
Newcastle upon Tyne, NE77DN, United Kingdom
Related Publications (1)
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.
PMID: 38488976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth Reserach
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 8, 2006
First Posted
December 12, 2006
Study Start
December 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 11, 2012
Results First Posted
May 11, 2012
Record last verified: 2012-04