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A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT04312659
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson (China) Investment Ltd.

Brief Summary:
The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.

Condition or disease Intervention/treatment
Crohn Disease Drug: Infliximab

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : August 14, 2023
Estimated Study Completion Date : August 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Infliximab
Participants with pediatric Crohn's disease (CD) who were treated with Infliximab (IFX) and signed the Informed Consent Form (ICF) for the study will be enrolled case by case. Each participants will be followed up for at least 30 weeks. After 30 weeks, participants continuing IFX treatment will be followed up, with a maximum follow-up period of 102 weeks. The primary data source will be participants medical records for all data entered into the CRF.
Drug: Infliximab
Participants will be observed who were treated with Infliximab.




Primary Outcome Measures :
  1. Percentage of Participants with Clinical Response at Week 14 [ Time Frame: Week 14 ]
    Percentage of participants with clinical response at week 14 will be reported. Clinical response is defined as a decrease of PCDAI >=15 and total PCDAI <=30.

  2. Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability [ Time Frame: Up to 102 weeks ]
    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.


Secondary Outcome Measures :
  1. Percentage of Participants with Clinical Remission at Week 14 [ Time Frame: Week 14 ]
    Percentage of participants with clinical remission at week 14 will be reported. Clinical remission is defined as the total PCDAI <=10.

  2. Percentage of Participants with Clinical Remission at Week 30 [ Time Frame: Week 30 ]
    Percentage of participants with clinical remission at week 30 will be reported. Clinical remission is defined as the total PCDAI <=10.

  3. Percentage of Participants with Clinical Response at Week 30 [ Time Frame: Week 30 ]
    Percentage of participants with clinical response at week 30 will be reported. Clinical response defined as a decrease of PCDAI >=15 and total PCDAI<=30.

  4. Percentage of Participants with Endoscopic Remission at Week 30 [ Time Frame: Week 30 ]
    Percentage of participants with endoscopic remission at week 30 will be reported. Endoscopic remission is defined as a total simple endoscopic sore for CD (SES-CD) 0-2. SES-CD is an endoscopic scoring system for CD. It is based on the score of 0-3 of the following four endoscopic variables: ulcer size, ulcerated and affected surfaces, and stenosis determined in five ileocolonic segment.

  5. Change from Baseline in Height Z-Scores at Week 30 [ Time Frame: Baseline and Week 30 ]
    Change from baseline in height Z-score will be recorded directly into an electronic device and will be considered source data. Height will be measured in meters.

  6. Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30 [ Time Frame: Baseline and Week 30 ]
    Change from baseline in BMI Z-score (growth and development) will be recorded directly into an electronic device and will be considered source data. BMI will be calculated based on weight (kilograms)/height (meters square).

  7. Change from Baseline in Acute Response Indicators at Week 14 [ Time Frame: Baseline and Week 14 ]
    Change from baseline in acute response indicators (C response protein and erythrocyte sedimentation rate) at week 14 will be reported.

  8. Change from Baseline in White Blood Cells Countat Week 14 [ Time Frame: Baseline and Week 14 ]
    Change from baseline in white blood cells count (giga cells per liter) at week 14 and will be reported.

  9. Change from Baseline in Hemoglobin Levels at Week 14 [ Time Frame: Baseline and Week 14 ]
    Change from baseline in hemoglobin levels (grams per liter) will be reported at week 14.

  10. Change from Baseline in Platelet Count at Week 14 [ Time Frame: Baseline and Week 14 ]
    Change from baseline in platelet count (giga cells per liter) will be reported at week 14.

  11. Change from Baseline in Albumin Levels at Week 14 [ Time Frame: Baseline and Week 14 ]
    Change from baseline in albumin levels (grams per liters) will be reported at week 14.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants observed in this study will be pediatric participants with Crohn's disease who have signed the ICF and are treated with infliximab.
Criteria

Inclusion Criteria:

  • Must have a confirmed diagnosis of Crohn's disease
  • Must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements
  • First-time received IFX treatment

Exclusion Criteria:

  • History of medical contraindications for Infliximab (IFX), example. serious infections, active tuberculosis (TB), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins
  • Previous exposure to Infliximab or any other biologics
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
  • Currently enrolled in an investigational study
  • Have other Crohn's-like disease that are associated with mono-genetic immune disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312659


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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China
Beijing Children's Hospital, Capital Medical University Not yet recruiting
Beijing, China, 100045
Guangzhou Women And Children's Medical Center Recruiting
Guangzhou, China, 510623
The Children's Hospital, Zhejiang University School Of Medicine Recruiting
Hangzhou, China, 310052
Ruijin Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, China, 200025
Children's Hospital of Fudan University Recruiting
Shanghai, China, 201102
Henan Children's Hospital, Zhengzhou Children's Hospital Not yet recruiting
ZhengZhou, China, 450018
Sponsors and Collaborators
Johnson & Johnson (China) Investment Ltd.
Investigators
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Study Director: Johnson & Johnson (China) Investment Ltd. Clinical Trial Johnson & Johnson (China) Investment Ltd.
Additional Information:
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Responsible Party: Johnson & Johnson (China) Investment Ltd.
ClinicalTrials.gov Identifier: NCT04312659    
Other Study ID Numbers: CR108748
C0168CRD4020 ( Other Identifier: Johnson & Johnson (China) Investment Ltd. )
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents