Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007163
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-12-09
Brief Title:
Monoclonal Antibody Treatment of Crohns Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose-Finding Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 J695 in Patients With Active Crohns Disease
Status:
COMPLETED
Status Verified Date:
2002-11
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 safety and effectiveness of an experimental drug called J695 for treating patients with Crohns disease-a long-term recurring inflammation of the small and large intestine This disease is currently treated with steroids sulfasalazine Azulfidine 5-ASA drugs Pentasa Asacol immune suppressants antibiotics and an antibody against TNF-alpha Despite the number and variety of available therapies for Crohns disease many patients do not respond adequately to treatment or they develop severe side effects from the medicines Therefore new treatments must be developed J695 is an antibody that is identical to a human antibody but chemically changed so that it can attach to and eliminate an inflammatory chemical made by the body called interleukin-12 IL-12 Animal studies have shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can also heal inflammation that has already developed
Patients 18 years of age and older who have had Crohns disease for at least 4 months may be eligible for this study Candidates will be screened with a medical history and physical examination electrocardiogram chest X-ray blood and urine tests stool analysis and possibly a review of medical records They will complete a Crohns Disease Activity Index Questionnaire for 7 days Participants will be randomly assigned to one of two treatment groups as follows
Group 1
Patients in this group will receive an injection of either J695 or placebo a solution that does not contain any active medicine under the skin on day 1 of the study on day 29 and then weekly for a total of seven injections After the last injection patients will be followed for an additional 18 weeks They will be monitored periodically throughout the study with physical examinations disease activity index scores and blood and urine tests
Group 2
Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections They will be followed for an additional 18 weeks Patients will be monitored as described above for group 1
Participants may be asked to undergo additional tests as part of a sub-study in this protocol These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation
Patients 18 years of age and older who have had Crohns disease for at least 4 months may be eligible for this study Candidates will be screened with a medical history and physical examination electrocardiogram chest X-ray blood and urine tests stool analysis and possibly a review of medical records They will complete a Crohns Disease Activity Index Questionnaire for 7 days Participants will be randomly assigned to one of two treatment groups as follows
Group 1
Patients in this group will receive an injection of either J695 or placebo a solution that does not contain any active medicine under the skin on day 1 of the study on day 29 and then weekly for a total of seven injections After the last injection patients will be followed for an additional 18 weeks They will be monitored periodically throughout the study with physical examinations disease activity index scores and blood and urine tests
Group 2
Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections They will be followed for an additional 18 weeks Patients will be monitored as described above for group 1
Participants may be asked to undergo additional tests as part of a sub-study in this protocol These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation
Detailed Description:
The purpose of this study is to evaluate the safety of and the clinical response to a human monoclonal anti-interleukin-12 antibody J695 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 two compelling observations First 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-TNF alpha 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 for the treatment of Crohns disease need to be developed and tested Second studies in both animals and humans support a central role for IL-12 in the gut inflammatory response in Crohns disease Administration of anti-IL-12 antibodies in animal models has prevented inducible or ameliorated established colitis For these reasons IL-12 is an appropriate therapeutic target for the treatment of Crohns disease
This study proposes to measure the toxicity and clinical effect of two doses of anti-IL-12 J695 administered subcutaneously to patients with moderately active Crohns disease The primary outcome measure is the rate and severity of adverse events Secondary outcome measures include J695 pharmacodynamics incidence of anti-J695 antibodies and clinical response A separate substudy at the NIH will measure gut lymphocyte apoptosis and gut and peripheral blood cytokine responses to study drug as well as endoscopic and histologic response to treatment Our short-term goal is to assure good tolerance of anti-IL-12 treatment regimens in Crohns disease patients and observe a beneficial clinical response The long-term goal of this study is to establish anti-IL-12 as an effective alternative with a low risk profile in the therapeutic armamentarium for Crohns disease
This study proposes to measure the toxicity and clinical effect of two doses of anti-IL-12 J695 administered subcutaneously to patients with moderately active Crohns disease The primary outcome measure is the rate and severity of adverse events Secondary outcome measures include J695 pharmacodynamics incidence of anti-J695 antibodies and clinical response A separate substudy at the NIH will measure gut lymphocyte apoptosis and gut and peripheral blood cytokine responses to study drug as well as endoscopic and histologic response to treatment Our short-term goal is to assure good tolerance of anti-IL-12 treatment regimens in Crohns disease patients and observe a beneficial clinical response The long-term goal of this study is to establish anti-IL-12 as an effective alternative with a low risk profile in the therapeutic armamentarium for 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 |
|---|---|---|---|
| 01-I-0040 | None | None | None |