Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT05906576 Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT05906576
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 6 to 17 years (inclusive), of any gender
  • Children who have been formally diagnosed with moderate to severe active Crohn's disease, based on established children's inflammatory bowel disease guidelines (confirm with trial site)
  • Children whose parent or guardian is willing and able to sign a consent form agreeing to participate and to allow data collection, in line with local laws
  • Children who have never previously received the medication infliximab

Who may not be able to join:

  • Children for whom infliximab is not considered medically safe, such as those with a serious active infection, active tuberculosis, lymphoma or other cancers, moderate to severe heart failure, or a known allergy to infliximab or related substances
  • Children who are already receiving other biological medicines that target a substance called TNF-α, or any other biological therapy
  • Children who have received or are planned to receive a live vaccine within 3 months before joining or during the treatment period
  • Children who have taken part in another clinical study within the 3 months before signing the consent form
  • Children whom the trial investigator considers unsuitable for inclusion in the study, for any reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Wu Jie, Beijing Children's Hospital

Phone: 18940251108

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Registry
ClinicalTrials.gov
Start date
21 September 2023
Est. completion
1 November 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Clinical response rate at 14 weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov