Indianapolis, INNCT05660746Now EnrollingIRB Ready

Crohn's Disease Clinical Trial in Indianapolis, IN

Access cutting-edge crohn's disease treatment through this phase 2/3 clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Children's Hospital Medical Center, Cincinnati

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Expert Care in Indianapolis

Access crohn's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related crohn's disease treatment provided free

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Check if you qualify for this crohn's disease clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Crohn's Disease Study in Indianapolis

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

Inclusion 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)

Exclusion Criteria

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 pathogen.
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 infection
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT05660746) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn's Disease Treatment Options in Indianapolis, IN

If you're searching for crohn's disease treatment options in Indianapolis, IN, this clinical trial (NCT05660746) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced crohn's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn's disease clinical trials near you to find additional studies recruiting in your area.

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