BridgeMD
New treatment option for Crohn Disease
Official title Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
ClinicalTrials.gov ID: NCT05781152
What this study is testing
What is Anti-TNF therapy?
Anti-TNF therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn disease.
Also referred to as Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Phase 1 1. Age ≥ 6 years and \< 18 years at enrollment
- Suspected diagnosis of CD
- Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium...
- Parent/guardian consent and patient assent
- 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...
You likely can't join if
- Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation
- Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with...
- Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)
- Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling
- Pregnancy
- Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
See the full eligibility criteria
- Phase 1 1. Age ≥ 6 years and \< 18 years at enrollment
- Suspected diagnosis of CD
- 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...
- Parent/guardian consent and patient assent
- 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
- Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation
- 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)
- Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)
- Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling
- Pregnancy
- Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
- 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)
- 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
- Inability to have MRE because of claustrophobia or other reasons Phase 2 Inclusion Criteria
- Met all eligibility criteria for Phase 1 and participated in Phase 1
- Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRE
- 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...
- Received at least one of the following as initial therapy upon diagnosis:
- Corticosteroids
- Immunomodulator
- Aminosalicylic acids (5-ASA)
- Defined nutritional therapy
- Anti-TNF (adalimumab or infliximab)
- 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...
- Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE
- Orofacial CD only
- Esophageal, gastric, duodenal, and/or jejunal CD only
- 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...
- Perianal CD only with no evidence of luminal disease
- Internal fistulizing disease at diagnosis
- Initial IBD treatment with non-anti-TNF biologic or small molecule therapy
- Received any anti-TNF agent other than adalimumab or infliximab
- Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up
- Inability to have MRE because of claustrophobia or other reasons
- Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required)
- Underwent bowel resection within 3 months of diagnosis (TD)
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Morristown, New Jersey, United States
- Lake Success, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.