Crohn Disease study: RoadMAB vs Infliximab
Official title Precise Infliximab Exposure and Pharmacodynamic Control
ClinicalTrials.gov ID: NCT05660746
What this study is testing
What is Infliximab?
An investigational biologic medicine being studied for Crohn disease. It is designed to block tumor necrosis factor-alpha, a protein involved in inflammation.
Also referred to as Remicade.
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
- The study wants to see if a precision‑dosing program that uses blood test results can help patients reach the best possible response to infliximab better than the usual dosing method.
- Who it's for
- The study is looking for people with Crohn’s disease, including both children and adults.
- What's involved
- Participants will receive infliximab treatment. Some will have their dose calculated by a computer program based on blood tests, while others will get the standard dose. Blood tests and other routine checks will be done to monitor the treatment.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 22
You may be able to join if
- Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old
- Written informed assent from patient when age appropriate
- Diagnosis of Crohn's disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at...
- ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
- Clinical activity and luminal inflammation, defined by both (1) and (2)
You likely can't join if
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
- Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
- Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
- Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
- Active perianal abscess (receiving oral antibiotics for \<7 days)
- Intestinal stricture (luminal narrowing with pre-stenotic dilation \>3 cm) and surgery planned in the next 90 days
See the full eligibility criteria
- Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old
- Written informed assent from patient when age appropriate
- Diagnosis of Crohn's disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at least 7 days)
- ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
- Clinical activity and luminal inflammation, defined by both (1) and (2)
- (1) PCDAI≥10 (\<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximab
- (2) SES-CD\>6, or SES-CD\>3 for isolated ileal disease (or a report of large intestinal ulcerations)\ within the last 60 days or a fecal calprotectin \>250 μg/g within last 75 days prior to screening
- C-reactive protein \>1.0 mg/dL in last 30 days and/or fecal calprotectin \>250 μg/g within last 75 days prior to screening
- Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
- Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
- Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
- Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
- Active perianal abscess (receiving oral antibiotics for \<7 days)
- Intestinal stricture (luminal narrowing with pre-stenotic dilation \>3 cm) and surgery planned in the next 90 days
- Have tested positive for Clostridium difficile toxin (stool assay) or other intestinal pathogens within 14 days of screening unless a repeat examination is negative and there are no signs of ongoing infection with that...
- Current hospitalization for complications of severe Crohn's disease
- Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
- Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (\>35 cm) or any CD surgery planned within the next 90 days
- History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
- Treatment with another investigational drug in the last four weeks
- History of malignancy (including lymphoma or leukemia)
- Currently receiving treatment for histoplasmosis
- History of TB, human immunodeficiency virus (HIV), an immunodeficiency syndrome, a central nervous system demyelinating disease, history of heart failure or receiving intravenous antibiotics in last 14 days for any...
- Currently pregnant, breast feeding or plans to become pregnant in the next 1 year
- Inability or failure to provide informed assent/consent
- Any developmental disabilities that would impede providing assent/consent
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Wilmington, Delaware, United States
- Jacksonville, Florida, United States
- Indianapolis, Indiana, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Norfolk, Virginia, United States
- Milwaukee, Wisconsin, United States
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, but 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 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States; Wilmington, Delaware, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.