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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:3/27/2019
Start Date:June 12, 2017
End Date:September 13, 2022
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-877-825-3327

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An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

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.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have CD. This study will look at the endoscopic remission and mucosal
healing of gastrointestinal tract of people who take vedolizumab as triple combination
therapy with adalimumab and methotrexate.

The study will enroll approximately 60 participants. Participants will receive triple
combination therapy which includes:

- Vedolizumab 300 mg (intravenous)

- Adalimumab 160/80/40 mg (subcutaneous)

- Methotrexate 15 mg (Oral)

All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22
along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg
once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets
orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will
receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and
102.

This multi-center trial will be conducted in the United States and Canada. The overall time
to participate in this study is 128 weeks. Participants will make multiple visits to the
clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up
assessment. Participants will also participate in a long-term safety questionnaire, by phone,
at 26 weeks (6 months) from the last dose of study drug.

Inclusion Criteria:

1. 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.

2. 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) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
abscess.

3. Has a known perianal fistula with abscess. (The participant may have a perianal
fistula without abscess.)

4. Has a known fistula (other than perianal fistula).
We found this trial at
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Clearwater, Florida 33762
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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Asheville, North Carolina 28801
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Atlanta, Georgia 30342
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Atlanta, Georgia 30312
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Baton Rouge, Louisiana 70809
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Calgary, Alberta
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1025 Morehead Medical Drive
Charlotte, North Carolina 28204
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Idaho Falls, Idaho 83404
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Las Vegas, Nevada 89113
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Maywood, Illinois 60153
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New York, New York 10029
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Plymouth, Minnesota 55446
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Pottsville, Pennsylvania 17901
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Salt Lake City, Utah 84132
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San Antonio, Texas 78229
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505 Nolen Drive
Southlake, Texas 76092
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2202 South Cedar Street
Tacoma, Washington 98405
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Tampa, Florida 33613
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Topeka, Kansas 66606
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Troy, Michigan 48098
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Tulsa, Oklahoma 74137
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Urbana, Illinois 61801
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Ypsilanti, Michigan 48197
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