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

Treatment Group Enbrel

Lek: 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.

Inne nazwy:

• etanercept

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.

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.

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.

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.

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.

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).

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).

Percentage of Participants Without Enthesitis

Percentage of Participants Without Peripheral Arthritis

Mean Occiput-to-wall Distance at Week 12 and Week 24

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.

Spine Agility Function by Ott Test

The Ott index determines the agility of the thoracic spine.