Status:
TERMINATED
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chronic Granulomatous Disease
Crohn'S-like IBD
Eligibility:
All Genders
10+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Chronic Granulomatous Disease (CGD) is an inherited immune disorder involving decreased phagocytic superoxide oxygen radical production, resulting in increased susceptibility to infections. Furthermor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Group One
- Must have a confirmed CGD diagnosis
- Must have IBD documented by medical history or documented IBD endoscopically.
- Must not be pregnant or breastfeeding
- Must have a home physician
- Must be willing to submit samples for storage.
- Group Two:
- Must have a confirmed CGD diagnosis
- Must have IBD documented by medical history or documented IBD endoscopically.
- Must be symptomatic
- Must have negative results on stool examination for culture of enteric pathogens, such as Salmonella, Shigella, Yersinia, Campylobacter, E. coli O157/H7, Clostridium difficile toxin assay, enteric parasites and their ova such as Cryptosporidia, Cyclospora, Microsporidia and Giardia (by stool enzyme immunoassay \[EIA\]) prior to the start of receiving TNF? inhibitors.
- Must not be pregnant or breastfeeding
- If of childbearing potential, one must agree to consistently use contraception, while on the study medication.
- Must have a recent chest CT (within 3 months) to confirm absence of tuberculosis (TB) infection
- Must have a home physician
- Must be willing to submit samples for storage.
- Group Three:
- Must be willing to undergo upper and lower endoscopy and mucosal biopsies for research purpose
- Must be greater than or equal to 18 years old and weigh greater than or equal to 15 kg.
- Must not be pregnant
- Must be willing to submit samples for storage.
- EXCLUSION CRITERIA:
- Group One:
- \- Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.
- Group Two:
- Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study
- Positive TB diagnosis
- Patients who are in the at-risk group for treatment such as history of tuberculosis, congestive cardiac failure or myocardial infarction within the last 12 months unstable angina, thrombocytopenia (platelet \< 100, 000), uncontrolled hypertension
- Acute systemic or intestinal infection(s)
- Evidence of Hepatitis B or C infection
- Signs and symptoms of hepatotoxicity
- Pregnant or breastfeeding
- History of cancer within the last 10 years
- The presence of certain types of acquired abnormalities of immunity such as HIV, cytotoxic chemotherapy for malignancy could be grounds for possible exclusion if, in the opinion of the investigator, the presence of such disease process interferes with evaluation of a co-existing abnormality of immunity that is a subject of study under this protocol.
- Co-existing Th2-type inflammatory disease
- Current active bowel obstruction, intestinal perforation, or significant GI hemorrhage.
- Live vaccine within 4 weeks prior to therapy or potential need for a live vaccine during the study.
- Unwillingness to undergo testing or procedures associated with this protocol.
- Group Three:
- Acute systemic or intestinal infection requiring antibiotics
- Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study
- The presence of certain types of acquired abnormalities of immunity such as HIV, cytotoxic chemotherapy for malignancy could be grounds for possible exclusion if, in the opinion of the investigator, the presence of such disease process interferes with evaluation of a co-existing abnormality of immunity that is a subject of study under this protocol.
- Unwillingness to undergo testing or procedures associated with this protocol.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00325078
Start Date
May 1 2006
End Date
June 1 2012
Last Update
December 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892