Triple Combination Therapy in High Risk Crohn's Disease (CD)

Completed · Phase 4

Conditions studied: Crohn Disease

In brief

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.

Key facts

Study ID

NCT02764762

Run by

Takeda

People needed

55

Starts

2017-04-18

Expected to finish

2022-07-05

Last updated by the study team

2023-07-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has an initial diagnosis of CD established within 24 months prior to screening with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
• Has moderate to severely active CD during Screening defined by a centrally assessed simple endoscopic score for Crohn disease (SES-CD) score >=7 (or >=4 if isolated ileal disease).

You may not qualify if…

• Gastrointestinal (GI) Exclusion Criteria
• Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.
• Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
• Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)
• Has a known fistula (other than perianal fistula).

Where it is running

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• Gastro Florida — Clearwater, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States
• Northshore University HealthSystem — Evanston, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Cotton O'Neil Clinical Research — Topeka, Kansas, United States
• Texas Digestive Disease Consultants Baton Rouge — Baton Rouge, Louisiana, United States
• Louisana Research Center, LLC — Shreveport, Louisiana, United States
• Center for Digestive Health — Troy, Michigan, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Minnesota Gastroenterology, PA - Plymouth — Plymouth, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Icahn School of Medicine at Mt. Sinai — New York, New York, United States
• Digestive Health Partners, PS — Asheville, North Carolina, United States
• Carolinas HealthCare System Digestive Health — Charlotte, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Digestive Disease Specialists, Inc. — Oklahoma City, Oklahoma, United States
• Options Health Research, LLC — Tulsa, Oklahoma, United States
• Baylor College of Medicine — Houston, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States
• Texas Digestive Disease Consultants Southlake — Southlake, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• Texas Digestive Disease Consultants, Webster — Webster, Texas, United States

Full record on ClinicalTrials.gov

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