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A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed in the past by radiography, histology, and/or endoscopy
  • Have moderately to severely active CD, defined as a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450, and either: a. Mean daily stool frequency (SF) count >3, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily abdominal pain (AP) score >1, based on the unweighted CDAI component of AP
  • Have endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening simple endoscopic score for crohn's disease (SES-CD) score >=6 (or >=4 for participants with isolated ileal disease), based on the presence of ulceration in at least 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. a minimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface"
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at baseline
  • Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

  • Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
  • Has previously demonstrated lack of initial response (that is, primary nonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to Vedolizumab
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers
  • History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly or monoclonal gammopathy of undetermined significance
  • Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof

Sites / Locations

  • Peking University Third HospitalRecruiting
  • The Military General Hospital of Beijing PLARecruiting
  • The second Xiangya Hospital of Central South UniversityRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Guangzhou First Municipal People's HospitalRecruiting
  • The 6th Affiliated Hospital of Sun Yat-Sen HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang UniversityRecruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
  • Anhui Province HospitalRecruiting
  • Huzhou central hospitalRecruiting
  • Jinhua municipal central hospitalRecruiting
  • The First Affiliated Hospital of NanChang UniversityRecruiting
  • Zhongda Hospital,Southeast UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Ningbo medical center lihuili hospitalRecruiting
  • Huashan Hospital Fudan UniversityRecruiting
  • Shanghai 10th Peoples HospitalRecruiting
  • Shanghai East HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Peking University Shenzhen HospitalRecruiting
  • The Second Hospital Affiliated To Suzhou UniversityRecruiting
  • Tongji Hospital, Tongji Medical College of HUSTRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Wuxi People's HospitalRecruiting
  • Yangzhou First People's HospitalRecruiting
  • Affiliated Hospital of Zunyi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ustekinumab

Arm Description

Participants will receive a single dose of ustekinumab intravenously (IV) (weight-based dose approximating 6 milligrams per kilogram [mg/kg]) at Week 0. Participants with body weight less than or equal to (<=) 55 kg will receive ustekinumab IV of 260 mg, greater than (>) 55 kg and <=85 kg will receive ustekinumab IV of 390 mg, and >85 kg will receive ustekinumab IV of 520 mg at Week 0 in induction phase followed by ustekinumab 90 mg subcutaneously (SC) in maintenance phase from Week 8 to Week 52. For participants who achieve clinical response with ustekinumab induction dosing at Week 8, will continue to receive 90 mg ustekinumab SC every 12 weeks with final dose at Week 44. If these participants meet the criteria for loss of response from Week 16 to Week 40, dose can be adjusted to 90 mg every 8 weeks (q8w). Participants who are non-responders to ustekinumab at Week 8, and achieve clinical response at Week 16, will continue to receive ustekinumab 90 mg SC q8w from Week 16 to Week 48.

Outcomes

Primary Outcome Measures

Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)
Clinical remission is defined as a crohn's disease activity index (CDAI) score of less than (<) 150 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). 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 or very soft stools, abdominal pain [AP]/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 that participants are to complete on a daily basis.
Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)
Endoscopic response is defined as at least 50 percent (%) improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or SES-CD score less than or equal to (<=) 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 56 [the most severe endoscopic activity]).

Secondary Outcome Measures

Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)
Percentage of participants with clinical remission at Week 52 will be reported.
Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)
PRO-2 remission is defined as an AP mean daily score at or below 1 (AP<=1) and a stool frequency (SF) mean daily score at or below 3 (SF<=3), and no worsening of AP or SF from baseline.
Percentage of Participants with Endoscopic Remission at Week 16 (Major Secondary Endpoint: Co-endpoint)
Endoscopic remission is defined as SES-CD score of <= 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 56 [the most severe endoscopic activity]).
Percentage of Participants with Endoscopic Response at Week 52
Percentage of participants with endoscopic response at Week 52 will be reported.
Percentage of Participants with Endoscopic Remission at Week 52
Percentage of participants with endoscopic remission at Week 52 will be reported.
Percentage of Participants with Clinical Remission at Week 3
Percentage of participants with clinical remission at Week 3 will be reported.
Percentage of Participants with PRO-2 Remission at Weeks 3 and 52
Percentage of participants with PRO-2 remission at Weeks 3 and 52 will be reported.
Percentage of Participants with Clinical Response at Weeks 3, 8, and 52
Clinical response is defined as a CDAI score decrease greater than or equal to (>=) 100 from baseline. Participants with a baseline CDAI score of >=220 to <=248 points are considered to be in clinical response if a CDAI score of <150 is attained.
Percentage of Participants with Clinical Remission at Week 52 (in Participants Induced into Clinical Remission with Ustekinumab at Week 8)
Percentage of participants with clinical remission at Week 52 (in participants induced into clinical remission with ustekinumab at Week 8) will be reported.
Percentage of Participants with Corticosteroid-free Remission at Week 52
Corticosteroid-free remission is defined as a CDAI score <150 and not taking any corticosteroids for at least 30 days or 90 days prior to Week 52.
Change from Baseline in C-reactive Protein (CRP) Concentration at Week 3, Week 8, and Week 52
Change from baseline in CRP concentration at Week 3, Week 8, and Week 52 will be reported.
Percentage of Participants with Normalization of CRP at Weeks 3, 8, and 52
Percentage of participants with normalization of CRP at Weeks 3, 8, and 52 with elevated CRP (>3.0 milligrams per liter [mg/L]) at baseline will be reported.
Change from Baseline in Fecal Calprotectin Concentration at Week 8 and Week 52
Change from baseline in fecal calprotectin concentration at Week 8 and Week 52 will reported. Fecal Calprotectin will be monitored as an inflammatory biomarker measured by assay.
Percentage of Participants with Normalization of Fecal Calprotectin at Weeks 8 and 52
Percentage of participants with normalization of fecal calprotectin at Weeks 8 and 52 with elevated fecal calprotectin (>250 milligrams per kilograms [mg/kg]) at baseline will be reported.
Percentage of Participants with Fistula Response at Weeks 8 and 52
Fistula response is defined as a >=50% reduction in the number of draining fistulas, among participants with 1 or more fistulas at baseline.
Percentage of Participants with Clinical Remission of Delayed Responders at Week 52
Percentage of participants with clinical remission of delayed responders at Week 52 will be reported. Delayed responders are participants who are not in clinical response to ustekinumab at Week 8 and achieve clinical response at Week 16.
Percentage of Participants with PRO-2 Remission of Delayed Responders at Week 52
Percentage of participants with PRO-2 remission of delayed responders at Week 52 will be reported.
Percentage of Participants with Clinical Response of Delayed Responders at Week 52
Percentage of participants with clinical response of delayed responders at Week 52 will be reported.
Percentage of Participants with Endoscopic Response of Delayed Responders at Week 52
Percentage of participants with endoscopic response of delayed responders at Week 52 will be reported.
Percentage of Participants with Endoscopic Remission of Delayed Responders at Week 52
Percentage of participants with endoscopic remission of delayed responders at Week 52 will be reported.
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 and Week 52
IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Percentage of Participants with IBDQ Response at Weeks 8 and 52
Percentage of participants with IBDQ response (>=16-point improvement from baseline) at Weeks 8 and 52 will be reported.
Percentage of Participants with IBDQ Remission at Weeks 8 and 52
Percentage of participants with IBDQ remission (>170-point) at Weeks 8 and 52 will be reported.
Percentage of Participants Having any Crohn's Disease (CD)-related Emergency Room (ER)/Hospitalizations (Including Surgeries) Through Week 8 and Week 52
Percentage of participants having any CD-related ER/hospitalizations (including surgeries) through Week 8 and Week 52 will be reported.
Percentage of Participants Having any CD-related Surgery and Procedure Through Week 8 and Week 52
Percentage of participants having any CD-related surgery and procedure through Week 8 and Week 52 will be reported.
Change from Baseline in Each of 4 Impairments from Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI-CD) at Week 8 and Week 52
The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.
Percentage of Participants with a 7-point Change from Baseline in Each of 4 Impairments from WPAI-CD at Week 8 and Week 52
The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.

Full Information

First Posted
August 30, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05029921
Brief Title
A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
Official Title
A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
May 28, 2025 (Anticipated)
Study Completion Date
May 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in Chinese participants with moderately to severely active Crohn's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ustekinumab
Arm Type
Experimental
Arm Description
Participants will receive a single dose of ustekinumab intravenously (IV) (weight-based dose approximating 6 milligrams per kilogram [mg/kg]) at Week 0. Participants with body weight less than or equal to (<=) 55 kg will receive ustekinumab IV of 260 mg, greater than (>) 55 kg and <=85 kg will receive ustekinumab IV of 390 mg, and >85 kg will receive ustekinumab IV of 520 mg at Week 0 in induction phase followed by ustekinumab 90 mg subcutaneously (SC) in maintenance phase from Week 8 to Week 52. For participants who achieve clinical response with ustekinumab induction dosing at Week 8, will continue to receive 90 mg ustekinumab SC every 12 weeks with final dose at Week 44. If these participants meet the criteria for loss of response from Week 16 to Week 40, dose can be adjusted to 90 mg every 8 weeks (q8w). Participants who are non-responders to ustekinumab at Week 8, and achieve clinical response at Week 16, will continue to receive ustekinumab 90 mg SC q8w from Week 16 to Week 48.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
STELARA
Intervention Description
Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.
Primary Outcome Measure Information:
Title
Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)
Description
Clinical remission is defined as a crohn's disease activity index (CDAI) score of less than (<) 150 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). 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 or very soft stools, abdominal pain [AP]/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 that participants are to complete on a daily basis.
Time Frame
Week 8
Title
Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)
Description
Endoscopic response is defined as at least 50 percent (%) improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or SES-CD score less than or equal to (<=) 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 56 [the most severe endoscopic activity]).
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)
Description
Percentage of participants with clinical remission at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)
Description
PRO-2 remission is defined as an AP mean daily score at or below 1 (AP<=1) and a stool frequency (SF) mean daily score at or below 3 (SF<=3), and no worsening of AP or SF from baseline.
Time Frame
Week 8
Title
Percentage of Participants with Endoscopic Remission at Week 16 (Major Secondary Endpoint: Co-endpoint)
Description
Endoscopic remission is defined as SES-CD score of <= 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 56 [the most severe endoscopic activity]).
Time Frame
Week 16
Title
Percentage of Participants with Endoscopic Response at Week 52
Description
Percentage of participants with endoscopic response at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Endoscopic Remission at Week 52
Description
Percentage of participants with endoscopic remission at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Clinical Remission at Week 3
Description
Percentage of participants with clinical remission at Week 3 will be reported.
Time Frame
Week 3
Title
Percentage of Participants with PRO-2 Remission at Weeks 3 and 52
Description
Percentage of participants with PRO-2 remission at Weeks 3 and 52 will be reported.
Time Frame
Weeks 3 and 52
Title
Percentage of Participants with Clinical Response at Weeks 3, 8, and 52
Description
Clinical response is defined as a CDAI score decrease greater than or equal to (>=) 100 from baseline. Participants with a baseline CDAI score of >=220 to <=248 points are considered to be in clinical response if a CDAI score of <150 is attained.
Time Frame
Weeks 3, 8, and 52
Title
Percentage of Participants with Clinical Remission at Week 52 (in Participants Induced into Clinical Remission with Ustekinumab at Week 8)
Description
Percentage of participants with clinical remission at Week 52 (in participants induced into clinical remission with ustekinumab at Week 8) will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Corticosteroid-free Remission at Week 52
Description
Corticosteroid-free remission is defined as a CDAI score <150 and not taking any corticosteroids for at least 30 days or 90 days prior to Week 52.
Time Frame
Week 52
Title
Change from Baseline in C-reactive Protein (CRP) Concentration at Week 3, Week 8, and Week 52
Description
Change from baseline in CRP concentration at Week 3, Week 8, and Week 52 will be reported.
Time Frame
Baseline, Week 3, Week 8, and Week 52
Title
Percentage of Participants with Normalization of CRP at Weeks 3, 8, and 52
Description
Percentage of participants with normalization of CRP at Weeks 3, 8, and 52 with elevated CRP (>3.0 milligrams per liter [mg/L]) at baseline will be reported.
Time Frame
Weeks 3, 8, and 52
Title
Change from Baseline in Fecal Calprotectin Concentration at Week 8 and Week 52
Description
Change from baseline in fecal calprotectin concentration at Week 8 and Week 52 will reported. Fecal Calprotectin will be monitored as an inflammatory biomarker measured by assay.
Time Frame
Baseline, Week 8, and Week 52
Title
Percentage of Participants with Normalization of Fecal Calprotectin at Weeks 8 and 52
Description
Percentage of participants with normalization of fecal calprotectin at Weeks 8 and 52 with elevated fecal calprotectin (>250 milligrams per kilograms [mg/kg]) at baseline will be reported.
Time Frame
Weeks 8 and 52
Title
Percentage of Participants with Fistula Response at Weeks 8 and 52
Description
Fistula response is defined as a >=50% reduction in the number of draining fistulas, among participants with 1 or more fistulas at baseline.
Time Frame
Weeks 8 and 52
Title
Percentage of Participants with Clinical Remission of Delayed Responders at Week 52
Description
Percentage of participants with clinical remission of delayed responders at Week 52 will be reported. Delayed responders are participants who are not in clinical response to ustekinumab at Week 8 and achieve clinical response at Week 16.
Time Frame
Week 52
Title
Percentage of Participants with PRO-2 Remission of Delayed Responders at Week 52
Description
Percentage of participants with PRO-2 remission of delayed responders at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Clinical Response of Delayed Responders at Week 52
Description
Percentage of participants with clinical response of delayed responders at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Endoscopic Response of Delayed Responders at Week 52
Description
Percentage of participants with endoscopic response of delayed responders at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Endoscopic Remission of Delayed Responders at Week 52
Description
Percentage of participants with endoscopic remission of delayed responders at Week 52 will be reported.
Time Frame
Week 52
Title
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 and Week 52
Description
IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time Frame
Baseline, Week 8 and Week 52
Title
Percentage of Participants with IBDQ Response at Weeks 8 and 52
Description
Percentage of participants with IBDQ response (>=16-point improvement from baseline) at Weeks 8 and 52 will be reported.
Time Frame
Weeks 8 and 52
Title
Percentage of Participants with IBDQ Remission at Weeks 8 and 52
Description
Percentage of participants with IBDQ remission (>170-point) at Weeks 8 and 52 will be reported.
Time Frame
Weeks 8 and 52
Title
Percentage of Participants Having any Crohn's Disease (CD)-related Emergency Room (ER)/Hospitalizations (Including Surgeries) Through Week 8 and Week 52
Description
Percentage of participants having any CD-related ER/hospitalizations (including surgeries) through Week 8 and Week 52 will be reported.
Time Frame
Weeks 8 and 52
Title
Percentage of Participants Having any CD-related Surgery and Procedure Through Week 8 and Week 52
Description
Percentage of participants having any CD-related surgery and procedure through Week 8 and Week 52 will be reported.
Time Frame
Weeks 8 and 52
Title
Change from Baseline in Each of 4 Impairments from Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI-CD) at Week 8 and Week 52
Description
The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.
Time Frame
Baseline, Week 8, and Week 52
Title
Percentage of Participants with a 7-point Change from Baseline in Each of 4 Impairments from WPAI-CD at Week 8 and Week 52
Description
The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.
Time Frame
Baseline, Week 8, and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed in the past by radiography, histology, and/or endoscopy Have moderately to severely active CD, defined as a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450, and either: a. Mean daily stool frequency (SF) count >3, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily abdominal pain (AP) score >1, based on the unweighted CDAI component of AP Have endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening simple endoscopic score for crohn's disease (SES-CD) score >=6 (or >=4 for participants with isolated ileal disease), based on the presence of ulceration in at least 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. a minimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface" A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at baseline Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion Criteria: Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab Has previously demonstrated lack of initial response (that is, primary nonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to Vedolizumab Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly or monoclonal gammopathy of undetermined significance Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
The Military General Hospital of Beijing PLA
City
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Name
The second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
The 6th Affiliated Hospital of Sun Yat-Sen Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Province Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Huzhou central hospital
City
Huzhou
ZIP/Postal Code
313099
Country
China
Individual Site Status
Recruiting
Facility Name
Jinhua municipal central hospital
City
Jinhua
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo medical center lihuili hospital
City
Ningbo
ZIP/Postal Code
315000
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai 10th Peoples Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital Affiliated To Suzhou University
City
Suzhou
ZIP/Postal Code
215168
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
ZIP/Postal Code
563000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

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