A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
Start Date
3/27/2025
Completion Date
6/1/2028
Summary
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Vedolizumab IV
Vedolizumab SC
Conditions
Locations
Gastro Health
Birmingham, Alabama 35243
United States
East View Medical Research
Mobile, Alabama 36608
United States
AZ Gastro Care
Chandler, Arizona 85225
United States
Spectrum Research Institute LLC
Gilbert, Arizona 85297
United States
GI Alliance- Sun City
Sun City, Arizona 85351
United States
UAMS Health Gastroenterology Clinic
Little Rock, Arkansas 72205
United States
Gastroenterology and Liver Institute
Escondido, California 92025
United States
Inland Empire Gastroenterology
Murrieta, California 92562
United States
United Clinical Research Institute
Murrieta, California 92563
United States
Digestive Health Institute
Newport Beach, California 92663
United States
Knowledge Research Center
Orange, California 92868
United States
Medical Associates Research Group, Inc.
San Diego, California 92123
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United States
Associates in Gastroenterology, PC
Colorado Springs, Colorado 80923
United States
Rocky Mountain Endocopy Centers LLC
Littleton, Colorado 80120
United States
Access Research Institute
Brooksville, Florida 34613
United States
Gastro Florida
Clearwater, Florida 33762
United States
Doral Medical Research, LLC
Hialeah, Florida 33016
United States
Digestive and Liver Center of Florida, P.A.
Kissimmee, Florida 34741
United States
Gastro Health Research - Miami
Miami, Florida 33176
United States
The Clinical Trials Network CTNX LLC
Orange City, Florida 32763
United States
Endoscopic Research, Inc.
Orlando, Florida 32803
United States
Orlando Health-Orlando Regional Medical Center
Orlando, Florida 32806
United States
Digestive and Liver Center of Florida
Orlando, Florida 32825
United States
Gastro Health Research - Pensacola
Pensacola, Florida 32504
United States
West Central Gastroenterology d/b/a Gastro Florida
Pinellas Park, Florida 33781
United States
Digestive Healthcare of Georgia
Atlanta, Georgia 30327
United States
AGA GA Research LLC
Atlanta, Georgia 30342
United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
United States
Yapp, Rockford M.D. (Private Practice)
Downers Grove, Illinois 60515
United States
GI Alliance - Glenview
Glenview, Illinois 60026
United States
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington, Illinois 60010
United States
Suburban Gastroenterology
Naperville, Illinois 60540
United States
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn, Illinois 60453
United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois 61107
United States
Springfield Clinic
Springfield, Illinois 62703
United States
Hutchinson Clinic
Hutchinson, Kansas 67502
United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky 41017
United States
Baton Rouge General Medical Center - Bluebonnet Campus
Baton Rouge, Louisiana 70809
United States
Combined Gastro LLC
Lafayette, Louisiana 70503
United States
GI Alliance
Metairie, Louisiana 70006
United States
Portland Gastroenterology Center
Portland, Maine 04101
United States
Capital Digestive Care
Chevy Chase, Maryland 20815
United States
Woodholme Gastroenterology
Glen Burnie, Maryland 21061
United States
Gastro Health Research - Framingham
Framingham, Massachusetts 01702
United States
Lucida Clinical Trials LLC
New Bedford, Massachusetts 02740
United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan 49519
United States
Huron Gastro
Ypsilanti, Michigan 48197
United States
MNGI Digestive Health, P.A.
Plymouth, Minnesota 55446
United States
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi 38671
United States
SSM Health Medical Group
Bridgeton, Missouri 63044
United States
GI Associates Research, LLC
Columbia, Missouri 65201
United States
Mid America Gastro Intestinal Consultants
Kansas City, Missouri 64111
United States
St Charles Clinical Research
Weldon Spring, Missouri 63304
United States
Advanced Research Institute
Reno, Nevada 89511
United States
Presbyterian Health care services
Albuquerque, New Mexico 87107
United States
Westchester Putnam Gastroenterology PC
Carmel, New York 10512
United States
Five Towns Gastroenterology
Cedarhurst, New York 11516
United States
IMIDeology
Elmhurst, New York 11373
United States
Intercity Gastroenterology
Fresh Meadows, New York 11040
United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York 11042
United States
Lenox Hill Hospital
New York, New York 10075
United States
New York Gastroenterology Associates
New York, New York 10075
United States
Manhattan Clinical Research, LLC
New York, New York 10279
United States
Gastroenterology Group of Rochester
Rochester, New York 14620
United States
ProHealth (Seaford) (Optum)
Seaford, New York 11783
United States
Syracuse VA Medical Center
Syracuse, New York 13210
United States
Digestive Disease Medicine
Utica, New York 13502
United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207
United States
Carolina Digestive Diseases
Greenville, North Carolina 27834
United States
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina 28374
United States
Piedmont Healthcare
Statesville, North Carolina 28625
United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina 28403
United States
Gastro Health Research - Cincinnati
Cincinnati, Ohio 45219
United States
DSI Research Northridge LLC
Dayton, Ohio 45414
United States
Gastro Health Research - Liberty Township
Liberty Township, Ohio 45044
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United States
DSI Research LLC
Springboro, Ohio 45066
United States
NorthShore Gastroenterology Research, LLC
Westlake, Ohio 44145
United States
The Oregon Clinic, P.C.
Portland, Oregon 97220
United States
University Gastroenterology
Providence, Rhode Island 02904
United States
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina 29486
United States
Sanford Center for Digestive Health
Sioux Falls, South Dakota 57105
United States
Tri-Cities Gastroenterology
Kingsport, Tennessee 37663
United States
The Clinical Trials Network CTNX LLC
El Paso, Texas 79936
United States
Amel Med LLC
Georgetown, Texas 78628
United States
Kelsey Research Foundation
Houston, Texas 77005
United States
MedCare Pharma LLC
Houston, Texas 77079
United States
Integrity Advanced Therapeutics
Houston, Texas 77090
United States
Spring Clinical Research
Houston, Texas 77090
United States
Gastro Health & Nutrition
Katy, Texas 77494
United States
One of a Kind Clinical Research Center LLC
Kingwood, Texas 77339
United States
West Texas Research Institute
Lubbock, Texas 79424
United States
Texas Gastro Consultants
Tomball, Texas 77375
United States
Digestive Research of Central Texas, LLC
Waco, Texas 76712
United States
GI Alliance - Webster
Webster, Texas 77598
United States
Advanced Research Institute
Ogden, Utah 84405
United States
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia 24014
United States
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
Suffolk, Virginia 23435
United States
TMPG Clinical Research
Williamsburg, Virginia 23188
United States
GI Alliance
Bellevue, Washington 98405
United States