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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959CRD4007 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab (GUS) | Drug | Guselkumab will be administered intravenously or by subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission At Week 48 | 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 600Íž higher score indicates higher disease activities. | At Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48 | 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 600Íž higher score indicates higher disease activities. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi'an Janssen Pharmaceutical Clinical Trial | Xi'an Janssen Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Sun Yat sen University | Recruiting | Guangzhou | 510060 | China | ||
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
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| At Weeks 12, 24 and 48 |
| Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24 | 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 600Íž higher score indicates higher disease activities. | At Weeks 12 and 24 |
| Percentage of Participants Achieving Endoscopic Response | 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 |
| Percentage of Participants Achieving Endoscopic Remission | 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 |
| Baseline Characteristics of Participants With Endoscopic Remission: Age | Baseline characteristics of participants (age) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: Sex | Baseline characteristics of participants (sex) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: Height | Baseline characteristics of participants (height) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: Weight | Baseline characteristics of participants (weight) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications | Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities | Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported. | Baseline |
| Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures | Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported. | Baseline |
| The Sixth Affiliated Hospital Sun Yat sen University |
| Recruiting |
| Guangzhou |
| 510655 |
| China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | 310018 | China |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | 230022 | China |
| Ruijin Hospital | Recruiting | Shanghai | 200031 | China |
| D007410 | Intestinal Diseases |