Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025805
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-10-25
Brief Title:
G-CSF to Treat Crohns Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Granulocyte-Colony Stimulating Factor Treatment for Crohns Disease A Pilot Study Assessing Immune and Clinical Response
Status:
COMPLETED
Status Verified Date:
2008-06-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effectiveness of G-CSF in treating patients with Crohns disease-a long-term recurring inflammation of the small and large intestine Patients may have swelling and bleeding of the intestinal lining which can lead to infection and abdominal pain weight loss fever diarrhea bloody stools fistula connections between the skin and intestine intestinal blockages and abscesses Although there are various treatments for Crohns disease many patients continue to have inflammation that is difficult to control or severe side effects from the medications G-CSF is an approved drug that is used to increase white blood cell counts Other cells immune cells exposed to G-CSF can develop a specific immune action-a Th-2 response-that decreases the inflammatory response in Crohns disease-a Th-1 response
Patients 18 years of age or older who have had mild to moderately severe Crohns disease for at least 4 months may be eligible for this study Candidates will be screened with a medical history and possible review of medical records physical examination blood tests electrocardiogram EKG urine and stool analyses and for women a pregnancy test They will fill out a Crohns Disease Activity Index questionnaire daily for 7 days and an Inflammatory Bowel Disease questionnaire
Participants will have G-CSF therapy Before starting therapy they will have a series of pre-treatment tests including a colonoscopy and leukapheresis Colonoscopy is an examination of the colon For the procedure patients are given a medication to lessen anxiety and any discomfort An endoscope-a lighted flexible tube-is inserted into the rectum allowing examination of the extent of inflammation The endoscope can also be used to take pictures of the colon and extract tissue samples for testing biopsy Leukapheresis is a procedure for collecting quantities of white blood cells Whole blood is collected through a needle placed in an arm vein and circulated through a machine that separates it into its components The white cells are removed and the rest of the blood is returned to the body either through the same needle used to draw the blood or through another needle placed in the other arm
After the colonoscopy and leukapheresis patients receive G-CSF injections every day for 29 days The patient or a caregiver such as a family member will be taught to give the injections Blood samples will be collected on treatment days 4 8 11 and 15 and a physical examination and interview blood tests and a stool exam will be done once a week Patients will have a repeat colonoscopy and leukapheresis 24 hours after the last treatment dose day 29
After the 29-day treatment patients will be followed in the clinic as follows
Week 4 after treatment - physical exam and interview routine blood work and stool exam
Week 8 - interview and blood work
Week 16 - interview blood work and stool exam
Week 24 - physical exam and interview blood work stool exam and colonoscopy
Patients 18 years of age or older who have had mild to moderately severe Crohns disease for at least 4 months may be eligible for this study Candidates will be screened with a medical history and possible review of medical records physical examination blood tests electrocardiogram EKG urine and stool analyses and for women a pregnancy test They will fill out a Crohns Disease Activity Index questionnaire daily for 7 days and an Inflammatory Bowel Disease questionnaire
Participants will have G-CSF therapy Before starting therapy they will have a series of pre-treatment tests including a colonoscopy and leukapheresis Colonoscopy is an examination of the colon For the procedure patients are given a medication to lessen anxiety and any discomfort An endoscope-a lighted flexible tube-is inserted into the rectum allowing examination of the extent of inflammation The endoscope can also be used to take pictures of the colon and extract tissue samples for testing biopsy Leukapheresis is a procedure for collecting quantities of white blood cells Whole blood is collected through a needle placed in an arm vein and circulated through a machine that separates it into its components The white cells are removed and the rest of the blood is returned to the body either through the same needle used to draw the blood or through another needle placed in the other arm
After the colonoscopy and leukapheresis patients receive G-CSF injections every day for 29 days The patient or a caregiver such as a family member will be taught to give the injections Blood samples will be collected on treatment days 4 8 11 and 15 and a physical examination and interview blood tests and a stool exam will be done once a week Patients will have a repeat colonoscopy and leukapheresis 24 hours after the last treatment dose day 29
After the 29-day treatment patients will be followed in the clinic as follows
Week 4 after treatment - physical exam and interview routine blood work and stool exam
Week 8 - interview and blood work
Week 16 - interview blood work and stool exam
Week 24 - physical exam and interview blood work stool exam and colonoscopy
Detailed Description:
The purpose of this pilot study is to evaluate the immunologic and the clinical response to granulocyte-colony stimulating factor G-CSF Filgrastim Neupogen administered to patients with Crohns Disease Crohns disease an incurable chronic relapsing inflammation of the small and large intestine affects approximately 500000 people in the United States The disease is characterized by full-thickness involvement of the gut wall leading to episodes of abdominal pain diarrhea hematochezia weight loss and complications such as bowel obstruction fistula formation and extraintestinal manifestations The rationale for this study is based on several observations First it has been shown that effector T cells and dendritic cells harvested following G-CSF administration display a Th2 phenotype Second Crohns disease in animal models has been characterized as a Th1 inflammatory disease that is susceptible to Th2 counter-regulation Lastly G-CSF has been an effective treatment in Crohns disease as well as other colitides with resemblance to Crohns disease according to published case reports Despite the standard therapeutic use of steroids aminosalicylates antibiotics antimetabolite immunosuppressants 6-MP methotrexate and early agents of the emerging biologics class of drugs anti-TNFalpha antibodies eg the treatment of Crohns disease is still troubled by loss of effectiveness of standard therapy over time outright nonresponsiveness and serious medication side effects For these reasons newer agents and strategies for the treatment of Crohns disease need to be developed and tested
This pilot study proposes to measure the immunologic and clinical effect of two dose levels of G-CSF administered subcutaneously to patients with active Crohns disease The primary outcomes include documenting changes in immune parameters by measuring peripheral and lamina propria CD4 T cell cytokine release dendritic cell phenotype and cytokine release and changes in clinical parameters such as the Crohns Disease Activity Index and endoscopic and histologic scores Secondary endpoints include the rate and severity of adverse events Our short-term goal is to document production of effector cells that have a Th2-cytokine profile and associate clinical improvement with these changes The long-term goal of this study is to establish G-CSF as an effective alternative or adjunctive therapy with a low risk profile for the treatment of Crohns disease
This pilot study proposes to measure the immunologic and clinical effect of two dose levels of G-CSF administered subcutaneously to patients with active Crohns disease The primary outcomes include documenting changes in immune parameters by measuring peripheral and lamina propria CD4 T cell cytokine release dendritic cell phenotype and cytokine release and changes in clinical parameters such as the Crohns Disease Activity Index and endoscopic and histologic scores Secondary endpoints include the rate and severity of adverse events Our short-term goal is to document production of effector cells that have a Th2-cytokine profile and associate clinical improvement with these changes The long-term goal of this study is to establish G-CSF as an effective alternative or adjunctive therapy with a low risk profile for the treatment of Crohns disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-0019 | None | None | None |