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

Spondylitis, Ankylosing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188655
• Other study ID #: 0881X1-4456
• Secondary ID: B1801095
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: September 8, 2011
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Enbrel
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 24	No
Secondary	Change From Baseline in BASDAI at Week 12 and 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.	Baseline, Week 12 and Week 24	No
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.	Baseline, Week 12 and Week 24	No
Secondary	Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24	Measured using a 100mm VAS ranging from 0=very good to 100=very bad.	Week 12 and Week 24	No
Secondary	Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24	Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.	Week 12 and Week 24	No
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).	Week 12 and Week 24	No
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).	Baseline, Week 12 and Week 24	No
Secondary	Percentage of Participants Without Enthesitis		Week 12 and Week 24	No
Secondary	Percentage of Participants Without Peripheral Arthritis		Week 12 and Week 24	No
Secondary	Mean Occiput-to-wall Distance at Week 12 and Week 24		Week 12 and Week 24	No
Secondary	Spine Agility Function by Schober Test	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.	Week 12 and Week 24	No
Secondary	Spine Agility Function by Ott Test	The Ott index determines the agility of the thoracic spine.	Week 12 and Week 24	No

External Links

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