Extension Study Evaluating Etanercept in Ankylosing Spondylitis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: Enbrel (etanercept)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
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).
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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.
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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).
Number of Patients With Sick Leave During 48 Weeks Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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.
Number of Sick Days Per Patient During the 48 Weeks of Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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.
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Total Back Pain Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	84
Study Start Date:	December 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Enbrel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410046

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

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth Reserach

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00410046 History of Changes
Other Study ID Numbers:	0881A3-405
Study First Received:	December 8, 2006
Results First Received:	October 30, 2009
Last Updated:	April 9, 2012
Health Authority:	Denmark: National Board of Health

Additional relevant MeSH terms:

Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013