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Completed

NCT Number: NCT01188655

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

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.

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Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enbrel

Drug

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.

Other names: etanercept

Primary outcomes

  1. Percentage of Participants Achieving BASDAI 40 Response at Week 24

    Time frame: 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 outcomes

  1. Change From Baseline in BASDAI at Week 12 and 24

    Time frame: 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.

  2. Change From Baseline in the BASFI at Weeks 12 and 24

    Time frame: 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.

  3. Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24

    Time frame: Week 12 and Week 24

    Measured using a 100mm VAS ranging from 0=very good to 100=very bad.

  4. Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24

    Time frame: 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.

  5. Mean Duration of Morning Stiffness

    Time frame: 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).

  6. Change From Baseline in ASQoL at Week 12 and Week 24

    Time frame: 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).

  7. Percentage of Participants Without Enthesitis

    Time frame: Week 12 and Week 24

  8. Percentage of Participants Without Peripheral Arthritis

    Time frame: Week 12 and Week 24

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

    Time frame: Week 12 and Week 24

  10. Spine Agility Function by Schober Test

    Time frame: 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.

  11. Spine Agility Function by Ott Test

    Time frame: Week 12 and Week 24

    The Ott index determines the agility of the thoracic spine.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2010
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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