A Study to Evaluate the Effectiveness and Safety of Triple Combination Therapy in High Risk Crohn's Disease (CD)

Overview

About this study

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 Crohn's Disease (CD) stratified at higher risk for complications.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Has an initial diagnosis of Chrohn's Disease (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 SES-CD score ≥7 (or ≥ 4 if isolated ileal disease).

Exclusion Criteria - Gastrointestinal (GI): 

  • 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Talha Malik, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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