Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01188655

Enrollment

Registered

2010-08-25

Start date

2008-05-31

Completion date

2010-03-31

Last updated

2011-09-12

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

Conditions

Spondylitis, Ankylosing

Keywords

Ankylosing Spondylitis

Brief summary

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

Detailed description

The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

Interventions

DRUGEnbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines * Patients treated as an outpatient

Exclusion criteria

* Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®. * Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections. * Patients with sepsis or risk of sepsis should not be treated.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving BASDAI 40 Response at Week 24	Week 24	BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant'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. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.

Secondary

Measure	Time frame	Description
Change From Baseline in the BASFI at Weeks 12 and 24	Baseline, Week 12 and Week 24	BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24	Week 12 and Week 24	Measured using a 100mm VAS ranging from 0=very good to 100=very bad.
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24	Week 12 and Week 24	Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.
Mean Duration of Morning Stiffness	Week 12 and Week 24	Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).
Change From Baseline in ASQoL at Week 12 and Week 24	Baseline, Week 12 and Week 24	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 participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant 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).
Change From Baseline in BASDAI at Week 12 and 24	Baseline, Week 12 and Week 24	BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant'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.
Percentage of Participants Without Peripheral Arthritis	Week 12 and Week 24	—
Mean Occiput-to-wall Distance at Week 12 and Week 24	Week 12 and Week 24	—
Spine Agility Function by Schober Test	Week 12 and Week 24	Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.
Spine Agility Function by Ott Test	Week 12 and Week 24	The Ott index determines the agility of the thoracic spine.
Percentage of Participants Without Enthesitis	Week 12 and Week 24	—

Participant flow

Participants by arm

Arm	Count
Etanercept Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.	89
Total	89

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lack of Efficacy	1
Overall Study	Lost to Follow-up	1
Overall Study	Other	11

Baseline characteristics

Characteristic	Etanercept
Age Continuous	41.6 Years STANDARD_DEVIATION 11.7
Ankylosing Spondylitis Quality of Life Scale (ASQoL) at baseline	11.9 Units on a scale STANDARD_DEVIATION 3.9
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline	5.3 units on a scale STANDARD_DEVIATION 1.6
Bath Ankylosing Spondylitis Functional Index (BASFI) at baseline	4.7 Units on a scale STANDARD_DEVIATION 2.3
Duration of morning stiffness at baseline	88.3 minutes STANDARD_DEVIATION 67.5
Occiput-to-wall distance	3.8 centimeter (cm) STANDARD_DEVIATION 6
Participant's Global Assessment Visual Analog Scale at baseline	6.7 Units on a scale STANDARD_DEVIATION 2
Percentage of Participants Without Enthesitis	57.5 Percentage of Participants
Percentage of Participants Without Peripheral Arthritis	70.1 Percentage of Participants
Physician's Global Assessment Visual Analog Scale at baseline	6.6 mm STANDARD_DEVIATION 1.4
Sex: Female, Male Female	32 Participants
Sex: Female, Male Male	57 Participants
Spine agility function by Ott test	11.8 cm STANDARD_DEVIATION 14.3
Spine agility function by Schober test	6.3 cm STANDARD_DEVIATION 5.5

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	3 / 89
serious Total, serious adverse events	0 / 89

Outcome results

Primary

Percentage of Participants Achieving BASDAI 40 Response at Week 24

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant'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. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.

Time frame: Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point

Arm	Measure	Value (NUMBER)
Etanercept	Percentage of Participants Achieving BASDAI 40 Response at Week 24	83.6 Percentage of participants

Secondary

Change From Baseline in ASQoL at Week 12 and Week 24

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 participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant 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).

Time frame: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Etanercept	Change From Baseline in ASQoL at Week 12 and Week 24	Week 12	-6.8 Units on a scale	Standard Deviation 4.2
Etanercept	Change From Baseline in ASQoL at Week 12 and Week 24	Week 24	-8.3 Units on a scale	Standard Deviation 5

Secondary

Change From Baseline in BASDAI at Week 12 and 24

Time frame: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Etanercept	Change From Baseline in BASDAI at Week 12 and 24	Week 12 (n= 70)	-2.8 units on a scale	Standard Deviation 2.4
Etanercept	Change From Baseline in BASDAI at Week 12 and 24	Week 24 (n= 68)	-3.5 units on a scale	Standard Deviation 2

Secondary

Change From Baseline in the BASFI at Weeks 12 and 24

BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.

Time frame: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Etanercept	Change From Baseline in the BASFI at Weeks 12 and 24	Week 12 (n= 73)	-2.1 Units on a scale	Standard Deviation 2.1
Etanercept	Change From Baseline in the BASFI at Weeks 12 and 24	Week 24 (n= 70)	-2.7 Units on a scale	Standard Deviation 2.1

Secondary

Mean Duration of Morning Stiffness

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).