Crohn DiseaseNCT04312659
A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
An observational study of Crohn Disease, run by Johnson & Johnson (China) Investment Ltd. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab
- How many people
- 38 participants
- Where
- 5 sitesChina
- Study dates
- 15 Jul 2020to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Guangzhou Women And Children's Medical Center
Guangzhou, 510623
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, 310052
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
Children's Hospital of Fudan University
Shanghai, 201102
Henan Children's Hospital, Zhengzhou Children's Hospital
Zhengzhou, 450018
About this study
Official title: A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
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.
- Conditions
- Crohn Disease
- Being tested
- Infliximab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Participants will be observed who were treated with Infliximab.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Clinical Response at 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.
Measured: Week 14
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
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.
Measured: Up to 102 weeks
Secondary outcomes (11)
Percentage of Participants with Clinical Remission at Week 14
Percentage of participants with clinical remission at week 14 will be reported. Clinical remission is defined as the total PCDAI <=10.
Measured: Week 14
Percentage of Participants with Clinical Remission at Week 30
Percentage of participants with clinical remission at week 30 will be reported. Clinical remission is defined as the total PCDAI <=10.
Measured: Week 30
Percentage of Participants with Clinical Response at 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.
Measured: Week 30
Percentage of Participants with Endoscopic Remission at 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.
Measured: Week 30
Change from Baseline in Height Z-Scores at 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.
Measured: Baseline and Week 30
Change from Baseline in Body Mass Index (BMI) Z-Scores at 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).
Measured: Baseline and Week 30
Change from Baseline in Acute Response Indicators at Week 14
Change from baseline in acute response indicators (C response protein and erythrocyte sedimentation rate) at week 14 will be reported.
Measured: Baseline and Week 14
Change from Baseline in White Blood Cells Countat Week 14
Change from baseline in white blood cells count (giga cells per liter) at week 14 and will be reported.
Measured: Baseline and Week 14
Change from Baseline in Hemoglobin Levels at Week 14
Change from baseline in hemoglobin levels (grams per liter) will be reported at week 14.
Measured: Baseline and Week 14
Change from Baseline in Platelet Count at Week 14
Change from baseline in platelet count (giga cells per liter) will be reported at week 14.
Measured: Baseline and Week 14
Change from Baseline in Albumin Levels at Week 14
Change from baseline in albumin levels (grams per liters) will be reported at week 14.
Measured: Baseline and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start15 Jul 2020
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson (China) Investment Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson (China) Investment Ltd. Clinical Trial, Study director, Johnson & Johnson (China) Investment Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312659
- Sponsor's protocol ID
- CR108748
- Other IDs
- C0168CRD4020
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04312659
- Acronym / sponsor ID
- CR108748
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johnson & Johnson (China) Investment Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | Drug: InfliximabParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabParticipants will be observed who were treated with Infliximab. | Drug | Infliximab |
Primary outcome
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.
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.
11 secondary outcomes
Percentage of Participants with Clinical Remission at Week 14
Time frame: Week 14
Percentage of Participants with Clinical Remission at Week 30
Time frame: Week 30
Percentage of Participants with Clinical Response at Week 30
Time frame: Week 30
Percentage of Participants with Endoscopic Remission at Week 30
Time frame: Week 30
Change from Baseline in Height Z-Scores at Week 30
Time frame: Baseline and Week 30
Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30
Time frame: Baseline and Week 30
Change from Baseline in Acute Response Indicators at Week 14
Time frame: Baseline and Week 14
Change from Baseline in White Blood Cells Countat Week 14
Time frame: Baseline and Week 14
Change from Baseline in Hemoglobin Levels at Week 14
Time frame: Baseline and Week 14
Change from Baseline in Platelet Count at Week 14
Time frame: Baseline and Week 14
Change from Baseline in Albumin Levels at Week 14
Time frame: Baseline and Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson (China) Investment Ltd. Clinical Trial study director
Johnson & Johnson (China) Investment Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Johnson & Johnson (China) Investment Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Clinical Response at Week 14 (time frame: Week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.