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A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Crohn's Disease

Thank you

Trial Information

A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease


Inclusion Criteria:



- Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within
prior 12 months. Diagnosed for at least 3 months

- Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450

- Failed conventional therapy or steroid dependent

Exclusion Criteria:

- Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non
colonic/ileal disease

- Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal
anastomosis

- History of diverticulitis, or evidence of Gastrointestinal (GI) perforations

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects with clinical remission as measured by the Crohn's Disease Activity Index

Outcome Time Frame:

At 8 weeks during the Induction Period

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

IM133-005

NCT ID:

NCT01545050

Start Date:

June 2012

Completion Date:

September 2017

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location
Duke University Medical Center Durham, North Carolina  27710
University of Florida Gainesville, Florida  32610-0277
University of Louisville Louisville, Kentucky  40202
Local Institution Vancouver, Washington  
University of California, San Diego La Jolla, California  92037-1709
Local Institution Wilmington, North Carolina  
Local Institution Chattanooga, Tennessee  
Options Health Research, Llc Tulsa, Oklahoma  74104
Gastro One Germantown, Tennessee  38138
Precision Research Institute, LLC San Diego, California  92114
Premier Medical Group of the Hudson Valley, PC Poughkeepsie, New York  12601
South Denver Gastroenterology, Pc Lone Tree, Colorado  80124
Djl Research, Pllc Charlotte, North Carolina  28210
Gastrointestinal Research Institute Newton, Pennsylvania  18940