Vedolizumab Subcutaneous Long-Term Open-Label Extension Study



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:12/26/2018
Start Date:April 15, 2016
End Date:February 10, 2022
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-877-825-3327

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A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease

The purpose of this study is to obtain long term safety and tolerability data of vedolizumab
subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's
disease (CD).

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC).
Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating
participants with UC or CD. This study will look at the long-term side effects and
response/remission of UC and CD in participants who received vedolizumab SC in a prior
vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have
previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who
completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a
clinical response at Week 6 but who did achieve a clinical response at Week 14 after having
received a third vedolizumab IV infusion at Week 6 in their previous study, will receive
open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early
from the Maintenance Period of their previous study due to disease worsening or need for
rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW).
Participants who experience treatment failure (disease worsening or need for rescue
medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC
study will continue until vedolizumab SC becomes commercially available, the participant
withdraws from the study, or the sponsor decides to close the study. Participants will make
multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for
a follow-up assessment. Participants will also participate in a long-term safety follow-up,
by phone, at 6 months after the last dose of study drug.

Inclusion Criteria:

1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of
the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027
or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria:

1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or
MLN0002SC-3031, or at any time during this study.

2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular,
pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological,
coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other
medical disorder developed during or after participation in a prior vedolizumab study
that, in the opinion of the investigator, would confound the study results or
compromise participant safety.

3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related
adverse event (AE).
We found this trial at
48
sites
Little Rock, Arkansas 72204
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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610 3rd St # 206
Macon, Georgia 31201
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Macon, GA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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701 West Morse Boulevard
Winter Park, Florida 32789
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Atlanta, Georgia 30342
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Baton Rouge, Louisiana 70809
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Belton, Missouri 64012
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Charleston, South Carolina 29425
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Chesterfield, Michigan 48098
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Chevy Chase, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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4190 Juan D. Peron
Ciudad Autonoma Buenos Aires, Buenos Aires C1181
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Ciudad Autonoma Buenos Aires,
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Crestview Hills, Kentucky 41017
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Dayton, Ohio 45415
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Egg Harbor Township, New Jersey 08234
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Germantown, Tennessee 37138
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Great Neck, New York 11021
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Hamden, CT
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Idaho Falls, Idaho
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Inverness, Florida 34452
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Lafayette, Louisiana 70503
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Largo, FL
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2793 Shawnee Road
Lima, Ohio 45806
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Miami, Florida 33144
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410 Saybrook Road
Middletown, Connecticut 06457
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2645 North Mayfair Road
Milwaukee, Wisconsin 53226
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Naples, Florida 34102
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Ocean Springs, Mississippi 39564
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1200 Breckenridge Street
Owensboro, Kentucky 42303
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12151 Taft Street
Pembroke Pines, Florida 33026
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Perkasie, Pennsylvania 18944
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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520 East Euclid Avenue
San Antonio, Texas 78212
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Seattle, WA
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Shreveport, Louisiana 71103
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Topeka, KS
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Tulsa, Oklahoma 74137
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Tyler, TX
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Urbana, Illinois 61801
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Wheat Ridge, Colorado 80033
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Ypsilanti, Michigan 48197
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Zephyrhills, Florida 33542
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