True North, a research study for adults 18-75 with Ulcerative Colitis

Description

A phase 3 research study of an oral investigational medication as induction and maintenance therapy for adults ages 18 to 75 with moderate to severe ulcerative colitis. Note, study participants may receive the investigational medication or placebo.

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.


A special website has been created to provide more information about the True North Study. The website can help determine if you may qualify and includes information on what to expect if you are enrolled. Visit TrueNorthStudy.com to see if you qualify.

Study Start Date

May 2015

Estimated Completion Date

December 2018

Interventions

  • Drug: RPC1063
  • Drug: Placebo

Specialties

  • Internal Medicine: Gastroenterology
  • Nursing: Gastroenterology
  • Gastroenterology: Inflammatory Bowel Dz,Pharmacology/kinetics
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Colitis, Ulcerative
  • Colonic Diseases
  • Digestive System Diseases
  • Gastroenteritis
  • Inflammatory Bowel Diseases
  • Irritable Bowel Disease (IBD)

Study ID

Celgene -- RPC01-3101

Status

Unknown

Trial ID

NCT02435992

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

900

Sponsor

Celgene

Inclusion Criteria

  • Ulcerative Colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Exclusion Criteria

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
  • History of uveitis macular edema
  • Pregnancy, lactation, or a positive serum ?-human chorionic gonadotropin (?-hCG) measured during Screening

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (40)

Study Location Distance Name Phone Email
Celgene Study Site - Great Neck, New York 174.4 miles None None None
Celgene Study Site - New York, New York 187.1 miles None None None
Celgene Study Site - Baltimore, Maryland 358.9 miles None None None
Celgene Study Site - Chevy Chase, Maryland 391.7 miles None None None
Celgene Study Site - Jacksonville, North Carolina 625.7 miles None None None
Celgene Study Site - Springfield, Ohio 684.7 miles None None None
Celgene Study Site - Beavercreek, Ohio 700.5 miles None None None
Celgene Study Site - Cinncinnati, Ohio 737.6 miles None None None
Celgene Study Site - Lexington, Kentucky 768.6 miles None None None
Celgene Study Site - Asheville, North Carolina 773.5 miles None None None
Celgene Study Site - Columbia, South Carolina 786.3 miles None None None
Celgene Study Site - Orangeburg, South Carolina 810.8 miles None None None
Celgene Study Site - Louisville, Kentucky 823.2 miles None None None
Celgene Study Site - Oak Lawn, Illinois 856.5 miles None None None
Celgene Study Site - Atlanta, Georgia 929.9 miles None None None
Celgene Study Site - Bridgeton, Missouri 1,043.9 miles None None None
Celgene Study Site - St. Louis, Missouri 1,048.4 miles None None None
Celgene Study Site - Washington, Missouri 1,079.6 miles None None None
Celgene Study Site - Orlando, Florida 1,115.8 miles None None None
Celgene Study Site - Germantown, Tennessee 1,131.3 miles None None None
Celgene Study Site - Zephyrhills, Florida 1,159.5 miles None None None
Celgene Study Site - Largo, Florida 1,200.1 miles None None None
Celgene Study Site - Delray Beach, Florida 1,214.3 miles None None None
Celgene Study Site - Delray Beach, Florida 1,214.3 miles None None None
Celgene Study Site - Delray Beach, Florida 1,214.3 miles None None None
Celgene Study Site - North Little Rock, Arkansas 1,250.7 miles None None None
Celgene Study Site - Belton, Missouri 1,252.7 miles None None None
Celgene Study Site - Miami, Florida 1,262.4 miles None None None
Celgene Study Site - Coral Gables, Florida 1,263.4 miles None None None
Celgene Study Site - Palmetto Bay, Florida 1,274.6 miles None None None
Celgene Study Site - Baton Rouge, Louisiana 1,382.4 miles None None None
Celgene Study Site - Houston, Texas 1,609.5 miles None None None
Celgene Study Site - San Antonio, Texas 1,768.2 miles None None None
Celgene Study Site - Idaho Falls, Idaho 2,055.7 miles None None None
Celgene Study Site - Salt Lake City, Utah 2,094.1 miles None None None
Celgene Study Site - Tucson, Arizona 2,277.9 miles None None None
Celgene Study Site - Lancaster, California 2,570.3 miles None None None
Celgene Study Site - San Diego, California 2,579.1 miles None None None
Celgene Study Site - Anaheim, California 2,587.0 miles None None None
Celgene Study Site - Mission Hills, California 2,598.0 miles None None None

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