Extension Study Evaluating Etanercept in Ankylosing Spondylitis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00410046

Enrollment

Registered

2006-12-12

Start date

2006-12-31

Completion date

2008-10-31

Last updated

2012-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

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.

Interventions

DRUGEnbrel (etanercept)

Etanercept 50 mg SC injection once weekly

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	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).
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment	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).

Secondary

Measure	Time frame	Description
Number of Patients With Sick Leave During 48 Weeks Treatment	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.
Number of Sick Days Per Patient During the 48 Weeks of Treatment	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.
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38	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.
Change in Total Back Pain Score From Baseline to Week 38	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.
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38	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.
Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment	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.
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38	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.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38	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.
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38	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.
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38	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.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38	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.
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment	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).

Countries

Denmark, Finland, Sweden, United Kingdom

Participant flow

Recruitment details

Patients were recruited in Europe from November 2006 to January 2008.

Pre-assignment details

Patients in 0881A3-402 (NCT00247962) were randomized to receive etanercept (ETN) or sulphasalazine (SSZ). After completion, they were eligible for enrollment into this extension study and all patients received ETN. Outcome measure analysis kept the 0881A3-402 assignment of ETN or SSZ. This enabled an analysis of changes from the original baseline.

Participants by arm

Arm	Count
Etanercept Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.	84
Total	84

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	3
Overall Study	Lost to Follow-up	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Etanercept
Age Continuous	42.70 years STANDARD_DEVIATION 10.49
Sex: Female, Male Female	13 Participants
Sex: Female, Male Male	71 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	66 / 84
serious Total, serious adverse events	5 / 84

Outcome results

Primary

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).

Time frame: 96 weeks

Population: All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Arm	Measure	Group	Value (NUMBER)
Etanercept / ETN	Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment	Sick leave 48 weeks before treatment	27 patients
Etanercept / ETN	Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment	Sick leave during 48 weeks of treatment	23 patients

p-value: 0.576Fisher Exact

Primary

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).

Time frame: 96 weeks

Population: All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Arm	Measure	Group	Value (NUMBER)
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Hospitalization 48 weeks before treatment	6 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Hospitalization during 48 treatment weeks	4 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Therapeutic warm bath 48 weeks before treatment	8 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Therapeutic warm bath during 48 treatment weeks	4 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Visit to physiotherapist 48 weeks before treatment	26 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Visit to physiotherapist during 48 treatment weeks	11 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Out-patient physician 48 weeks before treatment	40 patients
Etanercept / ETN	Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	Out-patient physician during 48 treatment weeks	30 patients

p-value: 0.743Fisher Exact

Comparison: Comparison of percentagesp-value: 0.362Fisher Exact

p-value: 0.005Fisher Exact

p-value: 0.091Fisher Exact

Secondary

Change From Baseline Haywood Quality of Life Score From Baseline to Week 38

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.