クローン病（CD）を有する中国人参加者におけるGuselkumabの有効性を評価する研究
ウステキヌマブへの反応喪失後の中国人クローン病患者におけるガセルクマブの有効性
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
研究場所
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Guangzhou、中国、510655
- 募集
- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou、中国、510060
- 募集
- The First Affiliated Hospital Sun Yat sen University
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Hangzhou、中国、310018
- 募集
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hefei、中国、230022
- 募集
- The First Affiliated Hospital of Anhui Medical University
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Shanghai、中国、200031
- 募集
- Ruijin Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Exclusion Criteria:
- Received UST dose optimization or multiple intravenous therapy in maintenance phase
- Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- Is currently enrolled in an interventional clinical study
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- Have a current or be suspected to have an abscess
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Guselkumab Treatment
Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy. |
Guselkumab will be administered intravenously or by subcutaneous injection.
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 Clinical Remission At Week 48
時間枠：At Week 48
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Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was 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. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Week 48
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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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Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48
時間枠：At Weeks 12, 24 and 48
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Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was 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. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Weeks 12, 24 and 48
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Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24
時間枠：At Weeks 12 and 24
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Clinical remission is defined as < 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was 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. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. |
At Weeks 12 and 24
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Percentage of Participants Achieving Endoscopic Response
時間枠：At Weeks 24 and 48
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Endoscopic response is defined as >= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
At Weeks 24 and 48
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Percentage of Participants Achieving Endoscopic Remission
時間枠：At Weeks 24 and 48
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Endoscopic remission is defined as SES-CD less than or equal to (<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease. |
At Weeks 24 and 48
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Baseline Characteristics of Participants With Endoscopic Remission: Age
時間枠：Baseline
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Baseline characteristics of participants (age) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Sex
時間枠：Baseline
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Baseline characteristics of participants (sex) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Height
時間枠：Baseline
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Baseline characteristics of participants (height) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Weight
時間枠：Baseline
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Baseline characteristics of participants (weight) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications
時間枠：Baseline
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Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities
時間枠：Baseline
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Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported. |
Baseline
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Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures
時間枠：Baseline
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Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported. |
Baseline
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協力者と研究者
捜査官
- スタディディレクター：Xi'an Janssen Pharmaceutical Clinical Trial、Xi'an Janssen Pharmaceutical
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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
米国FDA規制機器製品の研究
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