Entyvio (Vedolizumab) Long Term Safety Study
Launched by TAKEDA · Feb 2, 2016
Trial Information
Current as of May 20, 2025
Completed
Keywords
ClinConnect Summary
The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab is being used to treat people who have UC or CD. This study will look at the long-term safety of vedolizumab versus other biologic agents in participants with UC or CD. The study will enroll approximately 5000 participants. All participants enrolled in this will belong to one of the two treatment group:
* Vedolizumab
* Other Biologic Agents -adalimumab, certolizumab pegol.
Golimumab and infliximab. Study drugs will be prescribed by the physician according to local prescribing information in t...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Signed informed consent, by the participant or a legally acceptable representative.
- • 2. Aged at least 18 years.
- • 3. Initiating vedolizumab or another biologic agent for UC or CD.
- • 4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.
- Exclusion Criteria:
- • 1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
- • 2. Prior treatment with vedolizumab.
- • 3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Birmingham, Alabama, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Iowa City, Iowa, United States
La Jolla, California, United States
Lebanon, New Hampshire, United States
Chicago, Illinois, United States
Madrid, , Spain
Dublin, , Ireland
Saskatoon, Saskatchewan, Canada
Palo Alto, California, United States
Seattle, Washington, United States
Chapel Hill, North Carolina, United States
Nashville, Tennessee, United States
Kansas City, Kansas, United States
Orlando, Florida, United States
Philadelphia, Pennsylvania, United States
Saint Louis, Missouri, United States
Chicago, Illinois, United States
Morristown, New Jersey, United States
Mobile, Alabama, United States
Charlottesville, Virginia, United States
Louisville, Kentucky, United States
Atlanta, Georgia, United States
Raleigh, North Carolina, United States
New York, New York, United States
Winston Salem, North Carolina, United States
Tucson, Arizona, United States
Worcester, Massachusetts, United States
Zagreb, , Croatia
Liege, , Belgium
Rochester, Minnesota, United States
Breda, , Netherlands
Silkeborg, , Denmark
Hvidovre, , Denmark
Heidelberg, , Germany
Liverpool, , United Kingdom
Manchester, , United Kingdom
Bobigny, , France
Kfar Saba, , Israel
Tel Aviv, , Israel
Greenville, North Carolina, United States
Tartu, , Estonia
New York, New York, United States
Rotterdam, , Netherlands
Dordrecht, , Netherlands
Saint Louis, Missouri, United States
Roma, , Italy
Osijek, , Croatia
New York, New York, United States
Rome, , Italy
Split, , Croatia
Metairie, Louisiana, United States
Houston, Texas, United States
Novara, , Italy
Naples, Florida, United States
Dublin 4, , Ireland
Newport, , United Kingdom
Topeka, Kansas, United States
St. Poelten, , Austria
Salford, , United Kingdom
Amsterdam, , Netherlands
Hamburg, , Germany
Evanston, Illinois, United States
Oak Lawn, Illinois, United States
Dublin 7, , Ireland
Ottignies, , Belgium
Pensacola, Florida, United States
Minden, , Germany
Great Neck, New York, United States
Houston, Texas, United States
Torrance, California, United States
London, , United Kingdom
Tel Aviv, , Israel
Dublin 8, , Ireland
Tartu, , Estonia
Leuven, , Belgium
Larbert, , United Kingdom
Bradford, , United Kingdom
Celje, , Slovenia
Amsterdam, , Netherlands
Southampton, , United Kingdom
Roma, , Italy
Afula, , Israel
Great Neck, New York, United States
Stockholm, , Sweden
Brussels, , Belgium
Pringy, , France
Rochester, New York, United States
Lisboa, , Portugal
Paris Cedex 14, , France
Chapel Hill, North Carolina, United States
Roma, , Italy
Leipzig, , Germany
Namur, , Belgium
Salzburg, , Austria
Breda, Gelderland, Netherlands
Dordrecht, South Holland, Netherlands
Torrance, California, United States
Hamden, Connecticut, United States
Middletown, Connecticut, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Suwanee, Georgia, United States
Arlington Heights, Illinois, United States
Maywood, Illinois, United States
Wichita, Kansas, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Ocean Spring, Mississippi, United States
Omaha, Nebraska, United States
Englewood, New Jersey, United States
Burnt Hills, New York, United States
Fishkill, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Fort Sam Houston, Texas, United States
Humble, Texas, United States
Oberosterreich, , Austria
Ried Im Innkreis, , Austria
Salzburg, , Austria
Wels, , Austria
Wien, , Austria
Wien, , Austria
Aalst, , Belgium
Bonheiden, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Bruxelles, , Belgium
Edegem, , Belgium
Genk, , Belgium
Gent, , Belgium
Gent, , Belgium
Gent, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Leuven, Flemish Brabant, , Belgium
Liege, , Belgium
Liege, , Belgium
Mechelen, , Belgium
Mons, , Belgium
Roeselare, , Belgium
Tournai, , Belgium
Kelowna, British Columbia, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
North Bay, Ontario, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Split, , Croatia
Aalborg, , Denmark
Copenhagen Nv, , Denmark
Copenhagen, , Denmark
Nykobing Falster, , Denmark
Tallinn, , Estonia
Tallinn, , Estonia
Amiens, , France
Angers, , France
Caen Cedex, , France
Chambray Les Tours, , France
Clermont Ferrand, , France
Colmar Cedex, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nice, , France
Nimes, , France
Paris, , France
Pessac Cedex, , France
Pierre Benite, , France
Reims, , France
Rouen, , France
Saint Etienne, , France
Toulouse Cedex 9, , France
Tourcoing Cedex, , France
Valenciennes, , France
Amberg, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Biberach, , Germany
Dachau, , Germany
Dessau Roslau, , Germany
Dresden, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt Am Main, , Germany
Frankfurt, , Germany
Halle (Saale), , Germany
Halle, , Germany
Halle, , Germany
Hamburg Eppendorf, , Germany
Heidelberg, , Germany
Herne, , Germany
Jerichow, , Germany
Kothen, , Germany
Leipzig, , Germany
Leipzig, , Germany
Ludwigshafen Am Rhein, , Germany
Luneburg, , Germany
Magdeburg, , Germany
Mainz, , Germany
Mannheim, , Germany
Mannheim, , Germany
Mannheim, , Germany
Munchen, , Germany
Munster, , Germany
Munster, , Germany
Nurnberg, , Germany
Regensburg, , Germany
Remscheid, , Germany
Russelsheim, , Germany
Saarbrucken, , Germany
Stade, , Germany
Tubingen, , Germany
Wiesbaden, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Cork, , Ireland
Galway, , Ireland
Beer Sheva, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petach Tikva, , Israel
Tel Aviv, , Israel
Zrifin, , Israel
Avellino Campania, , Italy
Brescia, , Italy
Brescia, , Italy
Catania, , Italy
Firenze, , Italy
Foggia 0301, Puglia, , Italy
Forli, , Italy
Messina, , Italy
Milano 3901, Lombardia, , Italy
Milano, , Italy
Milano, , Italy
Napoli 2007, Campania, , Italy
Palermo, , Italy
Roma, Lazio, , Italy
Roma, Lazio, , Italy
Roma, , Italy
Rome, , Italy
Salerno, , Italy
Torino, , Italy
Varese, , Italy
Amsterdam, , Netherlands
Sittard, , Netherlands
Bodo, , Norway
Hamar, , Norway
Nordbyhagen, , Norway
Oslo, , Norway
Maribor, , Slovenia
Badalona, , Spain
Hospitalet, , Spain
Pontevedra, , Spain
Terrasa, Barcelona, , Spain
Vigo, , Spain
Stockholm, , Sweden
Stockholm, , Sweden
Bern, , Switzerland
Bern, , Switzerland
St. Gallen, , Switzerland
Zurich, , Switzerland
Abergavenny, , United Kingdom
Blackpool, , United Kingdom
Camberley, Surrey, , United Kingdom
Coventry, , United Kingdom
Derby, , United Kingdom
Harrow, Middlesex, , United Kingdom
Hull, , United Kingdom
Keighley, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Sheffield, , United Kingdom
Shrewsbury, , United Kingdom
Southampton, Hampshire, , United Kingdom
Wakefield, , United Kingdom
Weston Super Mare, Avon, , United Kingdom
Wolverhampton, , United Kingdom
Worthing, West Sussex, , United Kingdom
Columbia, South Carolina, United States
Foggia 0301, , Italy
Milano 3901, , Italy
Napoli 2007, , Italy
Roma, , Italy
Terrasa, , Spain
Camberley, , United Kingdom
Harrow, , United Kingdom
Weston Super Mare, , United Kingdom
Worthing, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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