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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00410046
Registration number
NCT00410046
Ethics application status
Date submitted
8/12/2006
Date registered
12/12/2006
Date last updated
11/05/2012
Titles & IDs
Public title
Extension Study Evaluating Etanercept in Ankylosing Spondylitis
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Scientific title
An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
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Secondary ID [1]
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0881A3-405
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enbrel (etanercept)
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.
Treatment: Drugs: Enbrel (etanercept)
Etanercept 50 mg SC injection once weekly
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
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Assessment method [1]
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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).
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Timepoint [1]
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96 weeks
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Primary outcome [2]
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Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
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Assessment method [2]
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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).
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Timepoint [2]
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96 weeks
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Secondary outcome [1]
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Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
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Assessment method [1]
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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.
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Timepoint [1]
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48 weeks
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Secondary outcome [2]
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Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
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Assessment method [2]
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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).
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Timepoint [2]
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48 weeks
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Secondary outcome [3]
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Number of Patients With Sick Leave During 48 Weeks Treatment
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Assessment method [3]
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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.
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Timepoint [3]
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48 weeks
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Secondary outcome [4]
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Number of Sick Days Per Patient During the 48 Weeks of Treatment
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Assessment method [4]
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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.
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Timepoint [4]
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48 weeks
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Secondary outcome [5]
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Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and 38 weeks
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Secondary outcome [6]
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Change in Total Back Pain Score From Baseline to Week 38
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and 38 weeks
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Secondary outcome [7]
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Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and 38 weeks
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Secondary outcome [8]
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Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and 38 weeks
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Secondary outcome [9]
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Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline and 38 weeks
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Secondary outcome [10]
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Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline and 38 weeks
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Secondary outcome [11]
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Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline and 38 weeks
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Secondary outcome [12]
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Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline and 38 weeks
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Withdrawal from the ASCEND study for safety or any other reason.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Fredriksberg
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Country [2]
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Denmark
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State/province [2]
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Odense
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Country [3]
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Denmark
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State/province [3]
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Svendborg
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Country [4]
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Denmark
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State/province [4]
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Vejle
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Country [5]
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Finland
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State/province [5]
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Helsinki
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Country [6]
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Finland
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State/province [6]
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Hyvinkaa
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Country [7]
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Finland
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State/province [7]
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Kuopio
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Country [8]
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Finland
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State/province [8]
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Tampere
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Country [9]
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Sweden
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State/province [9]
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Stockholm
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Country [10]
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United Kingdom
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State/province [10]
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Basingstoke
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Country [11]
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United Kingdom
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State/province [11]
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Bath
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Country [12]
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United Kingdom
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State/province [12]
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Cambridge
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Country [13]
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United Kingdom
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State/province [13]
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Cannock
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Country [14]
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United Kingdom
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State/province [14]
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Liverpool
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Country [15]
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United Kingdom
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State/province [15]
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Newcastle upon Tyne
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Country [16]
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United Kingdom
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State/province [16]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Wyeth is now a wholly owned subsidiary of Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00410046
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Wyeth Reserach
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00410046
Download to PDF