Crohn DiseasePhase 4NCT05906576
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
A Phase 4 study testing Infliximab in people with Crohn Disease, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ranged 6 to 17 years (both inclusive), no gender limitation.
- A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
- Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
- The patient received infliximab for the first time.
Who cannot join
- Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
- Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
- The investigator judges the subject inappropriate to be included in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Wu Jie, 18940251108, licli2860@sina.com
About this study
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Read the detailed description
This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.
- 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
Also called CMAB008
Infliximab in the treatment of Crohn's disease in children
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | Infliximab for the treatment of Crohn's disease in children Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate at 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
Measured: up to 14 weeks
Secondary outcomes (9)
Clinical remission rate at week 14 and 54
Clinical remission: PCDAI≤10
Measured: up to 54 weeks
Endoscopic response rate at week 14 and 54
Endoscopic response: SES-CD decreased ≥ 50%
Measured: up to 54 weeks
Mucosal healing rate at week 14 and 54
Mucosal healing: SES-CD 0-2
Measured: up to 54 weeks
Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54
The z-score is converted from anthropometric measurements based on the World Health Organization growth reference. The z-score including: height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score.
Measured: up to 54 weeks
Changes from baseline in serum C-reactive protein at week 14 and 54
Changes from baseline in serum C-reactive protein at week 14 and 54
Measured: up to 54 weeks
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Measured: up to 54 weeks
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I
Measured: up to 54 weeks
ADA positive rate
ADA positive rate at week 14 and 54
Measured: up to 54 weeks
Percentage of participants with Adverse Events
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Measured: up to 102 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start21 Sep 2023
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wu Jie, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906576
- Sponsor's protocol ID
- C008CDIV
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT05906576
- Acronym / sponsor ID
- C008CDIV
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Jun 2023 (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.
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Detailed description
This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: InfliximabInfliximab for the treatment of Crohn's disease in children |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ranged 6 to 17 years (both inclusive), no gender limitation.
- A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
- Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
- The patient received infliximab for the first time.
Key exclusion criteria (5 listed)
- Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
- Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
- The investigator judges the subject inappropriate to be included in this study.
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 |
|---|---|---|
| InfliximabAlso: CMAB008Infliximab in the treatment of Crohn's disease in children | Drug | Infliximab |
Primary outcome
Clinical response rate at 14 weeks
Time frame: up to 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
9 secondary outcomes
Clinical remission rate at week 14 and 54
Time frame: up to 54 weeks
Endoscopic response rate at week 14 and 54
Time frame: up to 54 weeks
Mucosal healing rate at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in serum C-reactive protein at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
Time frame: up to 54 weeks
ADA positive rate
Time frame: up to 54 weeks
Percentage of participants with Adverse Events
Time frame: up to 102 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Wu Jie principal investigator
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab in people with Crohn Disease, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wu Jie (18940251108, licli2860@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate at 14 weeks (time frame: up to 14 weeks). 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 30 Sep 2026.