Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
This study will determine if the drug infliximab is safe for treating inflammatory bowel
disease (IBD) in patients with chronic granulomatous disease (CGD). IBD is an inflammation or
irritation of the gut that leads to symptoms such as diarrhea, bloating and stomach cramps.
CGD is an inherited disease affecting white blood cells called neutrophils in which patients
are susceptible to repeated bacterial and fungal infections. They also have a higher
incidence of some autoimmune diseases, such as IBD. Infliximab is approved to treat Crohn's
disease, an IBD similar to that seen in patients with CGD.
Patients 10 years of age and older with CGD and IBD may be eligible for this study.
Candidates are screened with a medical history, physical examination, blood and urine tests,
electrocardiogram (EKG), tuberculosis skin test (PPD skin testing), and stool test for the
presence of infections. Additional tests may be done, including colonoscopy (procedure using
a flexible tube through the rectum to examine the lining of the gut) and imaging studies such
as an x-ray, chest CT scan (test using a special x-ray machine), MRI (test using a magnetic
field and radio waves), and barium studies (study using a drinkable solution of barium to
help enhance the x-ray pictures of the gut).
Participants are divided into patients with IBD symptoms (Group 1) and patients without IBD
symptoms (Group 2) for the following procedures:
Group 1
Patients are evaluated every 6 months with a medical history and physical examination for
signs and symptoms of IBD. Patients who are taking moderate to high doses of steroid
medications have their medication slowly lowered (tapered) and are evaluated every 3 months
for a total of 2 years. Patients in this group who start to develop IBD symptoms are moved to
Group 2 for treatment with infliximab (see below).
Group 2
Patients in Group 2 receive infliximab infusions at 2-week intervals for three doses. The
drug is given over a 2-hour period through a catheter placed in a vein. Patients are
evaluated with a medical history, physical exam, and blood tests the day of each dose. One
week after the last dose, they have another evaluation, including a colonoscopy. Patients who
respond well to infliximab may continue to receive the drug every 2 months for a total of 1
year, with evaluations at every dosing visit. At the end of the first year of receiving
infliximab, all patients have follow-up evaluations every 6 months for a total of 2 years.
Group 3
Subjects who volunteer to undergo colonoscopy and research biopsies that serve as controls
for evaluation of the patient gut samples.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)