Extension Study Evaluating Etanercept in Ankylosing Spondylitis

April 9, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Fredriksberg, Denmark, DK-2000
      • Odense, Denmark, DK-5000
      • Svendborg, Denmark, DK-5700
      • Vejle, Denmark, DK-7100
  • Finland
      • Helsinki, Finland, FIN-130
      • Hyvinkaa, Finland, FIN-05800
      • Kuopio, Finland, FIN-70211
      • Tampere, Finland, FIN-33100
  • Sweden
      • Stockholm, Sweden, SE-17176
  • United Kingdom
      • Basingstoke, United Kingdom, RG249NA
      • Bath, United Kingdom, BA11RL
      • Cambridge, United Kingdom, CB22QQ
      • Cannock, United Kingdom, WS112XY
      • Liverpool, United Kingdom, L97AL
      • Newcastle upon Tyne, United Kingdom, NE77DN
      • Wirral, United Kingdom, CH495PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Enbrel (etanercept)
Etanercept 50 mg SC injection once weekly
Other Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Time Frame: 96 weeks
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
Time Frame: 96 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
Time Frame: 48 weeks
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 of treatment.
48 weeks
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
Time Frame: 48 weeks
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 all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).
48 weeks
Number of Patients With Sick Leave During 48 Weeks Treatment
Time Frame: 48 weeks
The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.
48 weeks
Number of Sick Days Per Patient During the 48 Weeks of Treatment
Time Frame: 48 weeks
Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.
48 weeks
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Time Frame: Baseline and 38 weeks
Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Total Back Pain Score From Baseline to Week 38
Time Frame: Baseline and 38 weeks
Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
Time Frame: Baseline and 38 weeks
BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
Time Frame: Baseline and 38 weeks
BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
Time Frame: Baseline and 38 weeks
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
Time Frame: Baseline and 38 weeks
BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
Time Frame: Baseline and 38 weeks
ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Baseline and 38 weeks
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
Time Frame: Baseline and 38 weeks
Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.
Baseline and 38 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth Reserach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A3-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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