Tracking Biologics Along the Silk Road (HARIR)
2019年1月9日 更新者：Janssen Pharmaceutica N.V., Belgium
The objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia.
調査の概要
研究の種類
観察的
入学 (実際)
140
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
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～65年 (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
Participants with confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis as their major disease for which they will be treated with REMICADE, SIMPONI, or STELARA within clinical practice.
説明
Inclusion Criteria:
- Participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis. A participant can be included for one disease only; participants with multiple diagnoses should be included for their major disease only
- Initiation of treatment with REMICADE, SIMPONI, or STELARA should be planned at the time of enrollment into this observational study (such treatment should be started within 30 days of enrollment)
- Participant must be either treatment-naïve to biologics or have been treated with no more than 2 different biologic agents before enrollment
- Participant must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria:
- Participant who have previously received treatment with REMICADE, SIMPONI, or STELARA must not be enrolled if they start the same therapy a second time
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before baseline data collection
- Participant is currently enrolled in an investigational study
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 |
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Cohort 1: Rheumatoid Arthritis
Participants with Rheumatoid arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
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Cohort 2: Ankylosing Spondylitis
Participants with Ankylosing spondylitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
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Cohort 3: Psoriatic Arthritis
Participants with Psoriatic arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
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Cohort 4: Crohn's Disease
Participants with Crohn's disease as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
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Cohort 5: Ulcerative Colitis
Participants with Ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
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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 American College of Rheumatology (ACR) 20 Response
時間枠：Year 2/early withdrawal
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The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas.
The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
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Year 2/early withdrawal
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Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
時間枠：Year 2/early withdrawal
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The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.
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Year 2/early withdrawal
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Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
時間枠：Year 2/early withdrawal
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The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.
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Year 2/early withdrawal
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Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response
時間枠：Year 2/early withdrawal
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The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation.
ASAS 20 = 20 percent improvement from baseline and an absolute change >= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
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Year 2/early withdrawal
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Percentage of Participants Achieving ASAS 40 Response
時間枠：Year 2/early withdrawal
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The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation.
The ASAS 40 = 40 percent improvement from baseline and an absolute change >= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
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Year 2/early withdrawal
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Percentage of Participants Achieving ASAS 5/6 Response
時間枠：Year 2/early withdrawal
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ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20 percent improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain.
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Year 2/early withdrawal
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Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)
時間枠：Year 2/early withdrawal
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The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
The last 4 variables are scored over 7 days by the participant on a diary card.
Clinical response defined as reduction of greater than or equal to 70 points and/or 25 percent from baseline in CDAI.
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Year 2/early withdrawal
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Number of Participants With Clinical Remission as Assessed by CDAI
時間枠：Year 2/early withdrawal
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The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
The last 4 variables are scored over 7 days by the participant on a diary card.
Remission will be defined as CDAI less than (<) 150 points.
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Year 2/early withdrawal
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease
時間枠：Baseline, Year 2/early withdrawal
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The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases.
Each question has graded responses from 1 (worst situation) to 7 (best situation).
Total score ranges from 32 (worst) to 224 (best).
Higher scores indicate better quality of life.
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Baseline, Year 2/early withdrawal
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Number of Participants With Clinical Response as Assessed by Mayo Score
時間枠：Year 2/early withdrawal
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Clinical response is defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and >= 3 points, and a decrease from baseline in the rectal bleeding sub score to 0 or 1.
The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe).
Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe.
Higher scores indicate worsening of the disease.
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Year 2/early withdrawal
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Number of Participants With Clinical Remission as Assessed by Mayo Score
時間枠：Year 2/early withdrawal
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Clinical remission is defined as a Mayo score less than or equal to 2 points, with no individual sub score greater than 1.
The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe).
Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe.
Higher scores indicate worsening of the disease.
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Year 2/early withdrawal
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis
時間枠：Year 2/early withdrawal
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The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases.
Each question has graded responses from 1 (worst situation) to 7 (best situation).
Total score ranges from 32 (worst) to 224 (best).
Higher scores indicate better quality of life.
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Year 2/early withdrawal
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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。
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 (実際)
2016年2月4日
一次修了 (実際)
2018年12月1日
研究の完了 (実際)
2018年12月1日
試験登録日
最初に提出
2016年12月28日
QC基準を満たした最初の提出物
2016年12月28日
最初の投稿 (見積もり)
2016年12月30日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月10日
QC基準を満たした最後の更新が送信されました
2019年1月9日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR106936
- C0168ARA4017 (その他の識別子：Janssen Pharmaceutica N.V., Belgium)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
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。