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New study aims to unlock why Anti-TNF drugs heal some Kids' Crohn's but not others

NCT ID NCT05781152

Disease control Sponsor: Connecticut Children's Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 900 children ages 6-17 who are newly diagnosed with Crohn's disease and starting anti-TNF therapy. Researchers will track healing of the intestine using blood tests, stool samples, colonoscopy, and MRI over one year. The goal is to understand why some children heal completely while others do not, so doctors can personalize treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-TNF therapy (biologic drugs like Remicade, Humira)
What this could lead to
If successful, this could help doctors personalize anti-TNF treatment for children with Crohn's, leading to better healing of the intestine.
What could go wrong
This is an observational study, not testing a new drug. It won't prove that anti-TNF works better than other treatments, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Phase 1 Inclusion Criteria 1. Age ≥ 6 years and \< 18 years at enrollment 2. Suspected diagnosis of CD 3. Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin. 4. Parent/guardian consent and patient assent 5. Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy Phase 1 Exclusion Criteria 1. Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation 2. Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture) 3. Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma) 4. Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling 5. Pregnancy 6. Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure) 7. Previous treatment with immunomodulators within one year of enrollment or anti-TNF therapy within two years of enrollment for other medical conditions (e.g., juvenile idiopathic arthritis) 8. Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitis 9. Inability to have MRE because of claustrophobia or other reasons Phase 2 Inclusion Criteria 1. Met all eligibility criteria for Phase 1 and participated in Phase 1 2. Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRE 3. MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details. 4. Received at least one of the following as initial therapy upon diagnosis: 1. Corticosteroids 2. Immunomodulator 3. Aminosalicylic acids (5-ASA) 4. Defined nutritional therapy 5. Anti-TNF (adalimumab or infliximab) 5. Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulator 6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing, OR c. Ileal biopsies are not obtained secondary to inflammatory or structural changes due to colonic CD. 7\. Parent/guardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapy Phase 2 Exclusion Criteria 1. Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE 2. Orofacial CD only 3. Esophageal, gastric, duodenal, and/or jejunal CD only 4. Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary. 5. Perianal CD only with no evidence of luminal disease 6. Internal fistulizing disease at diagnosis 7. Initial IBD treatment with non-anti-TNF biologic or small molecule therapy 8. Received any anti-TNF agent other than adalimumab or infliximab 9. Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up 10. Inability to have MRE because of claustrophobia or other reasons 11. Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required) 12. Underwent bowel resection within 3 months of diagnosis (TD)

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cedars-Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Children's Hospital Western Ontario

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Children's Hospital of Eastern Ontario

    RECRUITING

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19146, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cohen Children's Medical Center of NY

    RECRUITING

    Lake Success, New York, 11042, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Levine Children's

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Rady Children's Hospital - San Diego and University of California, San Diego

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92123, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children at Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Stollery Children's Hospital

    RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • The Johns Hopkins Children's Medical Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Toronto SickKids Hospital

    RECRUITING

    Toronto, Ontario, M5G1X8, Canada

  • UCSF Benioff Children's Hospitals

    RECRUITING

    San Francisco, California, 94158, United States

  • UH/Rainbow Babies and Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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