Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00138840
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
STA-5326 is an experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.
This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
- Is male or female aged 18 through 75 years.
- Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
- Has a Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive at Baseline.
- Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this study.
- Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-Up period.
- Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-Up period.
- Has clinically significant hematologic, hepatic or renal laboratory abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients achieving clinical remission and clinical response at Day 29
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving: a clinical remission at Days 29 and 43 a clinical response from Baseline to Day 29 and from Baseline to Day 43 a reduction in endoscopic scores from Baseline to Day 29 an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43 a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein
Trial Locations
- Locations (35)
Maryland Digestive Disease Research
🇺🇸Laurel, Maryland, United States
Capital Gastroenterology Consultants, P.A.
🇺🇸Silver Spring, Maryland, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Calgary Health Sciences
🇨🇦Calgary, Alberta, Canada
Southern Clinical Research Consultants
🇺🇸Hollywood, Florida, United States
London Health Science Center South Street Campus
🇨🇦London, Ontario, Canada
Atlanta Gastroenterology
🇺🇸Atlanta, Georgia, United States
Gastroenterology Associates
🇺🇸Little Rock, Arkansas, United States
Advanced Gastroenterology Highland Lakes Medical Center
🇺🇸Palm Harbor, Florida, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Pinehurst Medical Clinic
🇺🇸Pinehurst, North Carolina, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Borland Groover Clinic
🇺🇸Jacksonville, Florida, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Gastroenterology Center of the MidSouth
🇺🇸German Town, Tennessee, United States
Saskatoon Medical Specialists
🇨🇦Saskatoon, Saskatchewan, Canada
Asher Kornbluth, MD
🇺🇸New York, New York, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
🇺🇸Rochester, New York, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Gastroenterology Research Associates
🇺🇸Cedar Knolls, New Jersey, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Wake Research Associates, LLC.
🇺🇸Raleigh, North Carolina, United States
Columbia Gastroenterology Associates, P.A.
🇺🇸Columbia, South Carolina, United States
Carolina Digestive Health Associates
🇺🇸Charlotte, North Carolina, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
London Health Science Center University Campus
🇨🇦London, Ontario, Canada
Austin Gastroenterology
🇺🇸Austin, Texas, United States
Univ. of Louisville Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States