Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (IDEA)
2017年1月17日 更新者：AbbVie (prior sponsor, Abbott)
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
調査の概要
状態
完了
条件
詳細な説明
This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format.
Data were collected prospectively and retrospectively.
Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation.
Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period.
During this period four follow-up visits were planned for observation of the patient and documentation of data.
Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
研究の種類
観察的
入学 (実際)
452
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
確率サンプル
調査対象母集団
Study population consisted of participants with ankylosing spondylitis (AS) who were treated with adalimumab as per locally approved label and prescription guidelines.
The decision to be treated with adalimumab had to be independent from study inclusion.
説明
Inclusion Criteria:
- Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
- Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment
- Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines
- Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Exclusion Criteria:
- Had contraindications for the treatment with adalimumab
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
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
Participants with Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
|
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 |
|---|---|---|
|
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
時間枠：Month 0 (baseline) and Month 12
|
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity.
Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).
The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.
|
Month 0 (baseline) and Month 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Achieving BASDAI 50
時間枠：Month 3, Month 6 and Month 9
|
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity.
Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).
The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.
|
Month 3, Month 6 and Month 9
|
|
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline
時間枠：Month 3, Month 6, Month 9 and Month 12
|
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer).
The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR).
Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit.
Higher scores indicate higher disease activity.
Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.
|
Month 3, Month 6, Month 9 and Month 12
|
|
Mean Change in the Number of Hospital Inpatient Days
時間枠：12 months prior to month 0 (baseline) and 12 months prior to month 12
|
Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
|
12 months prior to month 0 (baseline) and 12 months prior to month 12
|
|
Mean Change in the Number of Hospitalizations
時間枠：12 months prior to month 0 (baseline) and 12 months prior to month 12
|
Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
|
12 months prior to month 0 (baseline) and 12 months prior to month 12
|
|
Mean Change in the Number of Sick Leave Days
時間枠：12 months prior to month 0 (baseline) and 12 months prior to month 12
|
Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)
|
12 months prior to month 0 (baseline) and 12 months prior to month 12
|
|
Mean Change in the Number of Sick Leaves
時間枠：12 months prior to month 0 (baseline) and 12 months prior to month 12
|
Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).
|
12 months prior to month 0 (baseline) and 12 months prior to month 12
|
|
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider
時間枠：12 months prior to month 0 (baseline) and 12 months prior to month 12
|
Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
|
12 months prior to month 0 (baseline) and 12 months prior to month 12
|
|
Mean Change From Baseline in BASDAI Score
時間枠：Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)
|
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity.
Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).
|
Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)
|
|
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score
時間枠：Month 3, Month 6, Month 9 and Month 12
|
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation.
The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer).
The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR).
Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit.
Higher scores indicate higher disease activity.
Remission is defined as ASDAS score <1.3.
Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.
|
Month 3, Month 6, Month 9 and Month 12
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
時間枠：Month 3, Month 6, Month 9 and Month 12
|
The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS.
It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment).
The mean of the ten questions was the total BASFI score.
A higher score indicates more severe impairment of functioning.
|
Month 3, Month 6, Month 9 and Month 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Liliana Iosub、AbbVie
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。
便利なリンク
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
2012年12月1日
一次修了 (実際)
2015年10月1日
研究の完了 (実際)
2015年10月1日
試験登録日
最初に提出
2012年12月19日
QC基準を満たした最初の提出物
2012年12月19日
最初の投稿 (見積もり)
2012年12月21日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月6日
QC基準を満たした最後の更新が送信されました
2017年1月17日
最終確認日
2017年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。