Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
2011年9月8日 更新者：Pfizer
Observational Non-Interventional Study With Enbrel 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.
調査の概要
詳細な説明
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 .
研究の種類
観察的
入学 (実際)
89
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Treatment Group Enbrel
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Achieving BASDAI 40 Response at Week 24
時間枠：Week 24
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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.
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Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in BASDAI at Week 12 and 24
時間枠：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.
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Baseline, Week 12 and Week 24
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Change From Baseline in the BASFI at Weeks 12 and 24
時間枠：Baseline, Week 12 and Week 24
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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.
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Baseline, Week 12 and Week 24
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Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
時間枠：Week 12 and Week 24
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Measured using a 100mm VAS ranging from 0=very good to 100=very bad.
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Week 12 and Week 24
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Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
時間枠：Week 12 and Week 24
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Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.
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Week 12 and Week 24
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Mean Duration of Morning Stiffness
時間枠：Week 12 and Week 24
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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).
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Week 12 and Week 24
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Change From Baseline in ASQoL at Week 12 and Week 24
時間枠：Baseline, Week 12 and Week 24
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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).
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Baseline, Week 12 and Week 24
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Percentage of Participants Without Enthesitis
時間枠：Week 12 and Week 24
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Week 12 and Week 24
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Percentage of Participants Without Peripheral Arthritis
時間枠：Week 12 and Week 24
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Week 12 and Week 24
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Mean Occiput-to-wall Distance at Week 12 and Week 24
時間枠：Week 12 and Week 24
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Week 12 and Week 24
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Spine Agility Function by Schober Test
時間枠：Week 12 and Week 24
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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.
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Week 12 and Week 24
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Spine Agility Function by Ott Test
時間枠：Week 12 and Week 24
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The Ott index determines the agility of the thoracic spine.
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Week 12 and Week 24
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スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年5月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2010年8月24日
QC基準を満たした最初の提出物
2010年8月24日
最初の投稿 (見積もり)
2010年8月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年9月12日
QC基準を満たした最後の更新が送信されました
2011年9月8日
最終確認日
2011年9月1日
詳しくは
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