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Набира участници Фаза 4 NCT06581328

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Ulcerative Colitis Crohn's Disease

Спонсор: Takeda

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria To be eligible to participate in this study, participants must meet all the following criteria: 1. In the investigator's opinion, the participant can understand and comply with protocol requirements. 2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures. 3. The participant is 18 to 80 years of age at the time of signing the ICF. 4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI). 5. If participant is a woman of childbearing potential (WOCBP): 1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab. 2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab. 3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab. 4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab. 6. If participant is a fertile man: 1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab 2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose. 7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following: 1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR 2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening 8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report. 9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy. Exclusion Criteria Participants who meet any of the following exclusion criteria will be excluded from participation in this study: 1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening. 2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments. 3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD). 4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024). 5. Received any investigational biologic therapy \<= 6 months prior to screening. 6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod). 7. The participant has any evidence of an active infection during screening. 8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome. 9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period. 10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment. 11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. 12. Has laboratory abnormalities during the screening period.
Интервенции
Vedolizumab IV
DRUG
Vedolizumab SC
DRUG
Места на провеждане 98
САЩ (98)
Presbyterian Health care services
Albuquerque , New Mexico
WITHDRAWN
Digestive Healthcare of Georgia
Atlanta , Georgia
AGA GA Research LLC
Atlanta , Georgia
Baton Rouge General Medical Center - Bluebonnet Campus
Baton Rouge , Louisiana
GI Alliance
Bellevue , Washington
Gastro Health Research- St. Vincents East
Birmingham , Alabama
ACTIVE_NOT_RECRUITING
Access Research Institute
Brooksville , Florida
Westchester Putnam Gastroenterology PC
Carmel , New York
Five Towns Gastroenterology
Cedarhurst , New York
ACTIVE_NOT_RECRUITING
AZ Gastro Care
Chandler , Arizona
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte , North Carolina
Capital Digestive Care
Chevy Chase , Maryland
Gastro Health Research - Cincinnati
Cincinnati , Ohio
Gastro Florida
Clearwater , Florida
Peak Gastroenterology Associates
Colorado Springs , Colorado
Associates in Gastroenterology, PC
Colorado Springs , Colorado
GI Associates Research, LLC
Columbia , Missouri
Tri-State Gastroenterology Associates
Crestview Hills , Kentucky
ACTIVE_NOT_RECRUITING
DSI Research Northridge LLC
Dayton , Ohio
Atlanta Center for Gastroenterology, P.C.
Decatur , Georgia
WITHDRAWN
Yapp, Rockford M.D. (Private Practice)
Downers Grove , Illinois
The Clinical Trials Network CTNX LLC
El Paso , Texas
IMIDeology
Elmhurst , New York
Gastroenterology and Liver Institute
Escondido , California
Gastro Health Research - Framingham
Framingham , Massachusetts
Intercity Gastroenterology
Fresh Meadows , New York
ACTIVE_NOT_RECRUITING
Amel Med LLC
Georgetown , Texas
Spectrum Research Institute LLC
Gilbert , Arizona
Woodholme Gastroenterology
Glen Burnie , Maryland
GI Alliance - Glenview
Glenview , Illinois
Doral Medical Research, LLC
Hialeah , Florida
WITHDRAWN
Kelsey Research Foundation
Houston , Texas
MedCare Pharma LLC
Houston , Texas
ACTIVE_NOT_RECRUITING
Integrity Advanced Therapeutics
Houston , Texas
WITHDRAWN
Spring Clinical Research
Houston , Texas
ACTIVE_NOT_RECRUITING
Hutchinson Clinic
Hutchinson , Kansas
Mid America Gastro Intestinal Consultants
Kansas City , Missouri
Tri-Cities Gastroenterology
Kingsport , Tennessee
One of a Kind Clinical Research Center LLC
Kingwood , Texas
Digestive and Liver Center of Florida, P.A.
Kissimmee , Florida
Combined Gastro LLC
Lafayette , Louisiana
ACTIVE_NOT_RECRUITING
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington , Illinois
NYU Langone Long Island Clinical Research Associates
Lake Success , New York
WITHDRAWN
Gastro Health Research - Liberty Township
Liberty Township , Ohio
UAMS Health Gastroenterology Clinic
Little Rock , Arkansas
WITHDRAWN
Rocky Mountain Endocopy Centers LLC
Littleton , Colorado
West Texas Research Institute
Lubbock , Texas
Great Lakes Gastroenterology Research, LLC
Mentor , Ohio
GI Alliance
Metairie , Louisiana
Gastro Health Research - Miami
Miami , Florida
East View Medical Research
Mobile , Alabama
Inland Empire Gastroenterology
Murrieta , California
WITHDRAWN
United Clinical Research Institute
Murrieta , California
ACTIVE_NOT_RECRUITING
Suburban Gastroenterology
Naperville , Illinois
WITHDRAWN
Lucida Clinical Trials LLC
New Bedford , Massachusetts
Lenox Hill Hospital
New York , New York
WITHDRAWN
New York Gastroenterology Associates
New York , New York
Manhattan Clinical Research, LLC
New York , New York
WITHDRAWN
Digestive Health Institute
Newport Beach , California
WITHDRAWN
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn , Illinois
Advanced Research Institute
Ogden , Utah
WITHDRAWN
Knowledge Research Center
Orange , California
WITHDRAWN
The Clinical Trials Network CTNX LLC
Orange City , Florida
Endoscopic Research, Inc.
Orlando , Florida
Orlando Health-Orlando Regional Medical Center
Orlando , Florida
Digestive and Liver Center of Florida
Orlando , Florida
WITHDRAWN
Gastro Health Research - Pensacola
Pensacola , Florida
Pinehurst Medical Clinic Inc
Pinehurst , North Carolina
WITHDRAWN
West Central Gastroenterology d/b/a Gastro Florida
Pinellas Park , Florida
MNGI Digestive Health, P.A.
Plymouth , Minnesota
WITHDRAWN
Portland Gastroenterology Center
Portland , Maine
The Oregon Clinic, P.C.
Portland , Oregon
University Gastroenterology
Providence , Rhode Island
Advanced Research Institute
Reno , Nevada
WITHDRAWN
Gastroenterology Consultants of Southwest Virginia.
Roanoke , Virginia
Gastroenterology Group of Rochester
Rochester , New York
WITHDRAWN
Rockford Gastroenterology Associates, Ltd.
Rockford , Illinois
Medical Associates Research Group, Inc.
San Diego , California
WITHDRAWN
ProHealth (Seaford) (Optum)
Seaford , New York
Sanford Center for Digestive Health
Sioux Falls , South Dakota
Delta Gastroenterology and Endoscopy Center
Southaven , Mississippi
DSI Research LLC
Springboro , Ohio
Springfield Clinic
Springfield , Illinois
Piedmont Healthcare
Statesville , North Carolina
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
Suffolk , Virginia
WITHDRAWN
Palmetto Primary Care Physician Division of Gastroenterology
Summerville , South Carolina
GI Alliance- Sun City
Sun City , Arizona
Syracuse VA Medical Center
Syracuse , New York
WITHDRAWN
Texas Gastro Consultants
Tomball , Texas
WITHDRAWN
Digestive Disease Medicine
Utica , New York
Digestive Research of Central Texas, LLC
Waco , Texas
GI Alliance - Webster
Webster , Texas
St Charles Clinical Research
Weldon Spring , Missouri
ACTIVE_NOT_RECRUITING
NorthShore Gastroenterology Research, LLC
Westlake , Ohio
TMPG Clinical Research
Williamsburg , Virginia
WITHDRAWN
Wilmington Gastroenterology Associates
Wilmington , North Carolina
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming , Michigan
Huron Gastro
Ypsilanti , Michigan
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
27.03.2025
Крайна дата
01.06.2028
Регистрационен номер
NCT06581328
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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