Clinical Outcomes of Children with Newly Diagnosed Crohn's Disease Treated with Anti-TNF Therapy
This study is for children and teenagers aged 6 to 17 who have been recently diagnosed with Crohn's disease (a condition causing inflammation in the digestive tract). Researchers want to see how well anti-TNF therapy works to heal the intestine. This treatment uses special medications given through IVs or shots to reduce inflammation. The study will look at whether participants achieve complete healing of their intestine after 52 weeks of starting anti-TNF therapy. The study plans to enroll 900 participants and is currently unclear if it is recruiting.
- Study design
- This is a prospective, multicenter, open-label, single-arm clinical trial with two phases, planning to enroll 900 participants in Phase 1.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Complete healing will be measured at 52 weeks from the start of anti-TNF therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
At a glance
Conditions
Where it's being run
26 sites across 18 statesStudy leadership
- Jeffrey S Hyams, MD · PRINCIPAL_INVESTIGATOR · Connecticut Children's Medical Center
- Subra Kugathasan, MD · PRINCIPAL_INVESTIGATOR · Emory University
- Lee Denson, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Complete healing (CH)52 weeks from anti-TNF start
The achievement of complete healing (CH) 52 weeks after initiation of anti-TNF therapy guided by ROADMAB™ (therapeutic drug monitoring) as evidenced by a composite of all of the following four features below: 1. Endoscopic healing (EH) determined by centrally read ileocolonoscopy (total SES-CD score \<3) 2. Transmural healing (TH) determined by centrally read MRE (no segmental MaRIAs score of ≥1) 3. Corticosteroid free for a minimum of 4 weeks 4. The absence of either intestinal resection or the addition of a nutritional, biological or small molecule therapeutic agent other than anti-TNF± concomitant IM