Study Description

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 receiving SC 108 mg Q2W 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.

Condition or Disease	Intervention/Treatment
Colitis, Ulcerative Crohn's Disease	Drug: Vedolizumab SC

Study Design

Study Type	Interventional
Actual Enrollment	746 participants
Design Allocation	Non-Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	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
Study Start Date	April 15, 2016
Actual Primary Completion Date	April 23, 2024
Actual Study Completion Date	April 23, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Group A: Vedolizumab SC 108 mg Q2W Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who: Completed the Maintenance Period (Week 52), or Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.	Drug: Vedolizumab SC Vedolizumab SC 108 mg injection
Group B: Vedolizumab SC 108 mg QW Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure. •Participants from current study who experience treatment failure while on study.	Drug: Vedolizumab SC Vedolizumab SC 108 mg injection

Outcome Measures

Primary Outcome Measures

1. Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment [From start of study medication through 18 weeks after the last dose]
   Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.

Secondary Outcome Measures

1. Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment [From start of study medication through 18 weeks after the last dose]
   Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
2. Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response [From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years]
   Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point.
3. Percentage of Participants with Crohn's Disease Achieving Clinical Response [From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years]
   Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only [defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52]).
4. Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission [From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years]
   Clinical remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1.
5. Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission [From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years]
   Clinical remission is defined as total HBI score of ≤4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).

Eligibility Criteria

Ages Eligible for Study	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	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	Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study. 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. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Contacts and Locations

Sponsors and Collaborators	Takeda
Locations	Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, Arizona, United States, 85307 Arkansas Primary Care Clinic, PA | Little Rock, Arkansas, United States, 72204 Rocky Mountain Clinical Research, LLC | Wheat Ridge, Colorado, United States, 80033 Medical Research Center of Connecticut, LLC | Hamden, Connecticut, United States, 06518 Middlesex Gastroenterology Associates | Middletown, Connecticut, United States, 06457 Nature Coast Clinical Research, LLC | Inverness, Florida, United States, 34452 Florida Center for Gastroenterology | Largo, Florida, United States, 33777 L & L Research Choices, Inc. | Miami, Florida, United States, 33176 Gastroenterology Group of Naples | Naples, Florida, United States, 34102 BRCR Medical Center, Inc. | Pembroke Pines, Florida, United States, 33028 Shafran Gastroenterology Center | Winter Park, Florida, United States, 32789 Florida Medical Clinic, P.A. | Zephyrhills, Florida, United States, 33542 Atlanta Gastroenterology Associates | Atlanta, Georgia, United States, 30342 Gastroenterology Associates of Central Georgia | Macon, Georgia, United States, 31201 Atlanta Gastroenterology Specialists, PC | Suwanee, Georgia, United States, 30024 Grand Teton Research Group, PLL | Idaho Falls, Idaho, United States, 83404 Rush University Medical Center | Chicago, Illinois, United States, 60612 Carle Foundation Hospital | Urbana, Illinois, United States, 61801 Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka, Kansas, United States, 66606 Tri-State Gastroenterology Associates | Crestview Hills, Kentucky, United States, 41017 Research Concierge, LLC | Owensboro, Kentucky, United States, 42303 Gastroenterology Associates, LLC | Baton Rouge, Louisiana, United States, 70809 Lafayette General Medical Center | Lafayette, Louisiana, United States, 70503 Louisiana Research Center, LLC | Shreveport, Louisiana, United States, 71103 Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research | Chevy Chase, Maryland, United States, 20815 Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan, United States, 48047 Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming, Michigan, United States, 49519 Huron Gastroenterology Associates | Ypsilanti, Michigan, United States, 48197 Mayo Clinic - Rochester | Rochester, Minnesota, United States, 55905 Digestive Health Center PA | Ocean Springs, Mississippi, United States, 39564 Ehrhardt Clinical Research, LLC | Belton, Missouri, United States, 64012 AGA Clinical Research Associates, LLC | Egg Harbor Township, New Jersey, United States, 08234 Long Island Clinical Research Associates | Great Neck, New York, United States, 11021 Premier Medical Group of the Hudson Valley, PC | Poughkeepsie, New York, United States, 12601 University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States, 27599 Dayton Gastroenterology, Inc | Dayton, Ohio, United States, 45415 Gastro-Enterology Research of Lima | Lima, Ohio, United States, 45806 Options Health Research | Tulsa, Oklahoma, United States, 74104 Main Line Gastroenterology Associates | Perkasie, Pennsylvania, United States, 18944 Medical University of South Carolina (MUSC) | Charleston, South Carolina, United States, 29425 Gastroenterology Center of the MidSouth PC | Germantown, Tennessee, United States, 38138 Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37232 San Antonio Gastroenterology | San Antonio, Texas, United States, 78212 Tyler Research Institute, LLC | Tyler, Texas, United States, 75701 Gastroenterology Associates of Tidewater | Chesapeake, Virginia, United States, 23320 Virginia Mason Seattle Main Clinic | Seattle, Washington, United States, 98101 Allegiance Research Specialists, LLC | Milwaukee, Wisconsin, United States, 53226 Hospital Italiano | Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1181ACH Centro de Investigaciones Medicas Mar del Plata | Mar del Plata, Buenos Aires, Argentina, B7600FYK Centro Medico Viamonte SRL | Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1120AAC Concord Repatriation General Hospital | Concord, New South Wales, Australia, 2139 Nepean Hospital | Kingswood, New South Wales, Australia, 2747 Mater Hospital Brisbane | South Brisbane, Queensland, Australia, 4101 Princess Alexandra Hospital | Woolloongabba, Queensland, Australia, 4102 Royal Adelaide Hospital | Adelaide, South Australia, Australia, 5000 Tennyson Centre Day Hospital | Kurralta Park, South Australia, Australia, 5037 Ballarat Base Hospital | Ballarat, Victoria, Australia, 3350 Monash Medical Centre Clayton | Bentleigh East, Victoria, Australia, 3165 St Vincent's Hospital Melbourne | Fitzroy, Victoria, Australia, 3065 St Frances Xavier Cabrini Hospital | Malvern, Victoria, Australia, 3144 Royal Melbourne Hospital | Melbourne, Victoria, Australia, 3000 The Alfred Hospital | Melbourne, Victoria, Australia, 3181 Fiona Stanley Hospital | Murdoch, Western Australia, Australia, 6150 St John of God Subiaco Hospital | Subiaco, Western Australia, Australia, 6008 Imeldaziekenhuis | Bonheiden, Belgium, 2820 AZ Sint-Lucas | Brugge, Belgium, 8310 Universitair Ziekenhuis Gent | Gent, Belgium, 9000 AZ Groeninge - Kennedylaan | Kortrijk, Belgium, 8500 ZNA Jan Palfijn | Merksem, Belgium, 2170 Clinique Saint-Pierre | Ottignies, Belgium, 1340 AZ Delta | Roeselare, Belgium, 8800 University Clinical Centre of the Republic of Srpska | Banja Luka, Bosnia and Herzegovina, 78000 University Clinical Hospital Mostar | Mostar, Bosnia and Herzegovina, 88000 Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiania, Goias, Brazil, 74535-170 HUGG - Hospital Universitario Gaffree e Guinle | Rio de Janeiro, Rio Do Janeiro, Brazil, 20270-004 HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro | Rio de Janeiro, Rio Do Janeiro, Brazil, 21941-913 Hospital Sao Vicente de Paulo | Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital de Clinicas de Porto Alegre | Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu, Sao Paulo, Brazil, 18618-970 Faculdade de Medicina do ABC | Santo Andre, Sao Paulo, Brazil, 09060-650 Irmandade da Santa Casa da Misericordia de Santos | Santos, Sao Paulo, Brazil, 11075-900 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000 "MHAT Avis - Medica" OOD | Pleven, Bulgaria, 5800 UMHAT 'Dr. Georgi Stranski', EAD | Pleven, Bulgaria, 5800 MHAT - Silistra AD | Silistra, Bulgaria, 7500 MC "Tsaritsa Yoanna' EOOD | Sliven, Bulgaria, 8800 MHAT "Hadzhi Dimitar", OOD | Sliven, Bulgaria, 8800 Second MHAT - Sofia AD | Sofia, Bulgaria, 1202 "City Clinic UMHAC" EOOD | Sofia, Bulgaria, 1407 Medical Center "Excelsior", OOD | Sofia, Bulgaria, 1407 UMHAT "Sv. Ivan Rilski", EAD | Sofia, Bulgaria, 1431 UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Sofia, Bulgaria, 1527 Fourth MHAT - Sofia EAD | Sofia, Bulgaria, 1606 Military Medical Academy - MHAT - Sofia | Sofia, Bulgaria, 1606 UMHAT 'Sveta Anna' AD | Sofia, Bulgaria, 1750 Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora, Bulgaria, 6000 Zeidler Ledcor Centre - University of Alberta | Edmonton, Alberta, Canada, T6G 2X8 PerCuro Clinical Research Ltd. | Victoria, British Columbia, Canada, V8V 3M9 LHSC - University Hospital | London, Ontario, Canada, N6A 5A5 LHSC - Victoria Hospital | London, Ontario, Canada, N6A 5W9 Toronto Digestive Disease Associates, Inc. | Vaughan, Ontario, Canada, L4L 4Y7 Clinical Hospital Centre Osijek | Osijek, Croatia, 31000 Clinical Hospital Centre Rijeka | Rijeka, Croatia, 51000 Special Hospital Medico | Rijeka, Croatia, 51000 Clinical Hospital Dubrava | Zagreb, Croatia, 10000 University hospital centre Zagreb | Zagreb, Croatia, 10000 CCBR - Czech Brno, s.r.o.. | Brno, Czechia, 60200 Hepato-Gastroenterologie HK s.r.o. | Hradec Kralove, Czechia, 500 12 A-SHINE s.r.o. | Plzen, Czechia, 31200 CLINTRIAL s.r.o. | Praha 10, Czechia, 100 00 CCBR Czech Prague, s.r.o. | Praha 3, Czechia, 13000 Axon Clinical s.r.o. | Praha 5, Czechia, 15000 Nemocnice Tabor a.s. | Tabor, Czechia, 39001 Odense Universitetshospital | Odense C, Denmark, 5000 Regionshospitalet Silkeborg | Silkeborg, Denmark, 8600 West Tallinn Central Hospital | Tallinn, Estonia, 10617 North Estonia Medical Centre Foundation | Tallinn, Estonia, 13419 Tartu University Hospital | Tartu, Estonia, 50406 LMU - Campus Grosshadern | Muenchen, Bayern, Germany, 81377 Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt, Hessen, Germany, 60590 Medizinische Hochschule Hannover | Hannover, Niedersachsen, Germany, 30625 Universitaetsklinikum Koeln | Koeln, Nordrhein Westfalen, Germany, 50937 Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz, Rheinland Pfalz, Germany, 55131 Universitaetsklinikum Magdeburg A.oe.R | Magdeburg, Sachsen Anhalt, Germany, 39120 EUGASTRO GmbH | Leipzig, Sachsen, Germany, 04103 Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel, Schleswig Holstein, Germany, 24105 Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Lubeck, Schleswig Holstein, Germany, 23538 Charite - Campus Virchow-Klinikum | Berlin, Germany, 13353 DRK Kliniken Berlin Westend | Berlin, Germany, 14050 Krankenhaus Waldfriede e. V. | Berlin, Germany, 14163 Obudai Egeszsegugyi Centrum Kft. | Budapest, Hungary, 1036 Semmelweis Egyetem | Budapest, Hungary, 1088 Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak | Budapest, Hungary, 1125 Pannonia Maganorvosi Centrum | Budapest, Hungary, 1136 Markhot Ferenc Oktatokorhaz es Rendelointezet | Eger, Hungary, 3300 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula, Hungary, 5700 Pest Megyei Flor Ferenc Korhaz | Kistarcsa, Hungary, 2143 Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc, Hungary, 3526 Karolina Korhaz-Rendelointezet | Mosonmagyarovar, Hungary, H-9200 Pecsi Tudomanyegyetem | Pecs, Hungary, 7624 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar, Hungary, 8000 Tolna Megyei Balassa Janos Korhaz | Szekszard, Hungary, 7100 HaEmek Medical Center | Afula, Israel, 18101 Barzilai Medical Center | Ashkelon, Israel, 78278 Soroka University Medical Center | Beer Sheva, Israel, 8410101 Rambam Health Care Campus | Haifa, Israel, 3109601 Wolfson Medical Center | Holon, Israel, 58100 Shaare Zedek Medical Center | Jerusalem, Israel, 91031 Galilee Medical Center | Nahariya, Israel, 2210001 Chaim Sheba Medical Center | Ramat Gan, Israel, 5265601 Kaplan Medical Center | Rechovot, Israel, 7610001 Tel Aviv Sourasky Medical Center | Tel Aviv, Israel, 6423906 IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo, Foggia, Italy, 71013 Istituto Clinico Humanitas | Rozzano, Milano, Italy, 20089 I.R.C.C.S Policlinico San Donato | San Donato Milanese, Milano, Italy, 20097 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna, Italy, 40138 Azienda Ospedaliera Ospedale Cannizzaro | Catania, Italy, 95100 Azienda Ospedaliera Universitaria Policlinico G. Martino | Messina, Italy, 98125 Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milano, Italy, 20157 A.O.U. Policlinico di Modena | Modena, Italy, 41124 Azienda Ospedaliera Universitaria "Federico II" | Napoli, Italy, 80131 Azienda Ospedaliera di Padova | Padova, Italy, 35128 Azienda Ospedaliera Vincenzo Cervello | Palermo, Italy, 90146 Azienda Ospedaliera San Camillo Forlanini | Roma, Italy, 00152 Policlinico Universitario Agostino Gemelli | Roma, Italy, 00168 Yokoyama IBD Clinic | Nagoya-shi, Aichi-Ken, Japan, 460-0022 Toho University Sakura Medical Center | Sakura-shi, Chiba-Ken, Japan, 285-8741 Ehime Prefectural Central Hospital | Matsuyama-shi, Ehime-Ken, Japan, 790-0024 Fukuoka University Chikushi Hospital | Chikushino-shi, Fukuoka-Ken, Japan, 818-8502 Fukuoka University Hospital | Fukuoka-shi, Fukuoka-Ken, Japan, 814-0180 Kurume University Hospital | Kurume-shi, Fukuoka-Ken, Japan, 830-0011 Hiroshima University Hospital | Hiroshima-shi, Hiroshima-Ken, Japan, 734-8551 Tokushukai Sapporo Tokushukai Hospital | Sapporo-shi, Hokkaido, Japan, 004-0041 Sapporo-Kosei General Hospital | Sapporo-shi, Hokkaido, Japan, 060-0033 Tokushukai Sapporo Higashi Tokushukai Hospital | Sapporo-shi, Hokkaido, Japan, 065-0033 Hyogo College of Medicine Hospital | Nishinomiya-shi, Hyogo-Ken, Japan, 663-8501 Iwate Medical University Hospital | Morioka-shi, Iwate-Ken, Japan, 020-8505 Kagawa Prefectural Central Hospital | Takamatsu-shi, Kagawa-Ken, Japan, 760-8557 Gokeikai Ofuna Chuo Hospital | Kamakura-shi, Kanagawa-Ken, Japan, 247-0056 Okayama University Hospital | Okayama-shi, Okayama-Ken, Japan, 700-8558 Kinshukai Infusion Clinic | Osaka-shi, Osaka-Fu, Japan, 530-0011 Osaka City General Hospital | Osaka-shi, Osaka-Fu, Japan, 534-0021 Saga University Hospital | Saga-shi, Saga-Ken, Japan, 849-8501 Shiga University of Medical Science Hospital | Otsu-shi, Shiga-Ken, Japan, 520-2192 Hamamatsu South Hospital | Hamamatsu-shi, Shizuoka-Ken, Japan, 430-0846 Medical Hospital, Tokyo Medical and Dental University | Bunkyo-ku, Tokyo-To, Japan, 113-8519 Jikei University Hospital | Minato-ku, Tokyo-To, Japan, 105-8471 Kitasato University Kitasato Institute Hospital | Minato-ku, Tokyo-To, Japan, 108-8642 Kyorin University Hospital | Mitaka-shi, Tokyo-To, Japan, 181-8611 Keio University Hospital | Shinjuku-ku, Tokyo-To, Japan, 160-8582 JCHO Tokyo Yamate Medical Center | Shinjuku-ku, Tokyo-To, Japan, 169-0073 Wakayama Medical University Hospital | Wakayama-shi, Wakayama-Ken, Japan, 641-8510 Kyungpook National University Hospital | Daegu, Gyeongsangbuk-do, Korea, Republic of, 41944 Yeungnam University Hospital | Daegu, Korea, Republic of, 42415 Kyung Hee University Hospital | Seoul, Korea, Republic of, 02447 Seoul National University Hospital | Seoul, Korea, Republic of, 03080 Kangbuk Samsung Hospital | Seoul, Korea, Republic of, 03181 Severance Hospital, Yonsei University | Seoul, Korea, Republic of, 03722 Asan Medical Center | Seoul, Korea, Republic of, 05505 Samsung Medical Center | Seoul, Korea, Republic of, 06351 Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas, Lithuania, 50009 Klaipeda Republican Hospital, Public Institution | Klaipeda, Lithuania, 92231 Klaipeda University Hospital, Public Institution | Klaipeda, Lithuania, 92288 Vilnius University Hospital Santariskiu Clinics, Public Institution | Vilnius, Lithuania, LT-08661 Morales Vargas Centro de Investigacion, S.C. | Leon, Guanajuato, Mexico, 37000 Centro de Investigacion Farmacologica del Bajio, S.C. | Leon, Guanajuato, Mexico, 37520 iBiomed Guadalajara | Zapopan, Jalisco, Mexico, 45030 Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey, Nuevo Leon, Mexico, 64460 Christus Muguerza Sur S.A. de C.V. | Monterrey, Nuevo Leon, Mexico, 64908 Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango, Mexico, 34000 Sociedad de Metabolismo y Corazon S.C | Veracruz, Mexico, 91910 Academisch Medisch Centrum | Amsterdam, Netherlands, 1105 AZ Albert Schweitzer Ziekenhuis | Dordrecht, Netherlands, 3317 NM Universitair Medisch Centrum Groningen (UMCG) | Groningen, Netherlands, 9713 GZ Maastricht University Medical Center | Maastricht, Netherlands, 6202 AZ Erasmus Medisch Centrum | Rotterdam, Netherlands, 3015 CE SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Bialystok, Poland, 15-275 NZOZ Vitamed | Bydgoszcz, Poland, 85-079 SP CSK im. prof. K. Gibinskiego SUM | Katowice, Poland, 40-752 Gabinet Endoskopii Przewodu Pokarmowego | Krakow, Poland, 31-009 SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM | Lodz, Poland, 90-153 Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz, Poland, 90-302 GASTROMED Sp. z o.o. | Lublin, Poland, 20-582 Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin, Poland, 71-434 Centrum Zdrowia MDM | Warszawa, Poland, 00-632 Centralny Szpital Kliniczny MSW w Warszawie | Warszawa, Poland, 02-507 Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warszawa, Poland, 02-781 Nzoz Vivamed | Warszawa, Poland, 03-580 LexMedica Osrodek Badan Klinicznych | Wroclaw, Poland, 53-114 Ars-Medica S.C Rybak Maria, Rybak Zbigniew | Wroclaw, Poland, 53-333 Spitalul Clinic Colentina | Bucuresti, Romania, 020125 Institutul Clinic Fundeni | Bucuresti, Romania, 022328 S.C Centrul de Gastroenterologie Dr. Goldis S.R.L | Timisoara, Romania, 300002 Kazan State Medical University | Kazan, Russian Federation, 420012 TSBIH "Territorial Clinical Hospital" | Krasnoyarsk, Russian Federation, 660022 FSBIH "Central Clinical Hospital of Russian Academy of Sciences" | Moscow, Russian Federation, 119333 LLC "Novosibirsk GastroCenter" | Novosibirsk, Russian Federation, 630007 SBEIHPE Novosibirsk State Medical University | Novosibirsk, Russian Federation, 630091 BHI of Omsk region "Clinical Oncology Dispensary" | Omsk, Russian Federation, 644013 SBEI HPE "Rostov State Medical University" of the MoH of the RF | Rostov-on-Don, Russian Federation, 344022 LLC "RIAT SPb" | Saint-Petersburg, Russian Federation, 197373 SPb SBIH "City Hospital # 40 of Kurortnyi region" | Sestroretsk, Russian Federation, 197706 SPb SBIH "City Hospital of Saint Martyr Elizaveta" | St. Petersburg, Russian Federation, 195257 Clinical Center of Serbia | Belgrade, Serbia, 11000 Clinical Helth Centre Zvezdara | Belgrade, Serbia, 11000 Military Medical Academy | Belgrade, Serbia, 11000 Clinical Center Bezanijska Kosa | Belgrade, Serbia, 11080 Clinical Center Zemun | Belgrade, Serbia, 11080 Clinical Center Kragujevac | Kragujevac, Serbia, 34000 Clinical Center Nis | Nis, Serbia, 18000 Clinical Center of Vojvodina | Novi Sad, Serbia, 21000 Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banska Bystrica, Slovakia, 97517 Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava, Slovakia, 82606 Gastroped s.r.o. | Kosice, Slovakia, 04001 KM Management spol. s r.o. | Nitra, Slovakia, 949 01 Gastro I, s.r.o. | Presov, Slovakia, 080 01 Dr CCM Ziady Practice | Pretoria, Gauteng, South Africa, 0181 Dr MJ Prins Practice | Cape Town, Western Cape, South Africa, 7500 Dr JP Wright Practice | Cape Town, Western Cape, South Africa, 7708 Hospital Universitari Germans Trias i Pujol | Badalona, Barcelona, Spain, 08916 Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda, Madrid, Spain, 28222 Hospital General Universitario de Alicante | Alicante, Spain, 03010 Hospital Universitari de Girona Dr Josep Trueta | Girona, Spain, 17007 Hospital Universitario Ramon y Cajal | Madrid, Spain, 28034 Complejo Hospitalario de Pontevedra | Pontevedra, Spain, 36164 Karolinska Universitetssjukhuset - Solna | Stockholm, Sweden, 171 76 Danderyds Sjukhus | Stockholm, Sweden, 182 88 National Taiwan University Hospital | Taipei, Taiwan, 100 Mackay Memorial Hospital | Taipei, Taiwan, 10449 Tri-Service General Hospital | Taipei, Taiwan, 11490 Ankara University Medical Faculty | Ankara, Turkey, 06100 Gazi University Medical Faculty | Ankara, Turkey, 06500 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul, Turkey, 34098 Acibadem Fulya Hospital | Istanbul, Turkey, 34349 Haydarpasa Numune Training and Research Hospital | Istanbul, Turkey, 34668 Marmara University Pendik Research and Training Hospital | Istanbul, Turkey, 34899 Kocaeli Derince Training and Research Hospital | Kocaeli, Turkey, 41380 Mersin University Medical Faculty | Mersin, Turkey, 33343 RCNECRCH Dept of Surgery, SHEI Ukr BSMU | Chernivtsi, Ukraine, 58002 SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU | Dnipro, Ukraine, 49074 Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU | Ivano-Frankivsk, Ukraine, 76008 CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv, Ukraine, 61037 CI A.and O. Tropiny City Clinical Hospital | Kherson, Ukraine, 73000 CI of Kyiv RC Kyiv Regional Clinical Hospital | Kyiv, Ukraine, 1023 MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE | Kyiv, Ukraine, 1023 Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU | Kyiv, Ukraine, 1103 Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU | Lviv, Ukraine, 79059 CI Odesa Regional Clinical Hospital | Odesa, Ukraine, 65025 Ternopil University Hospital | Ternopil, Ukraine, 46002 Private Small Enterprise Medical Center Pulse | Vinnytsia, Ukraine, 21001 Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia, Ukraine, 21005 MCIC MC LLC Health Clinic | Vinnytsia, Ukraine, 21009 CI City Hospital #1 | Zaporizhzhia, Ukraine, 69014 Royal Devon and Exeter Hospital (Wonford) | Exeter, Devon, United Kingdom, EX2 5DW Whipps Cross University Hospital | London, Greater London, United Kingdom, E11 1NR Royal Free Hospital | London, Greater London, United Kingdom, NW3 2QG St George's Hospital | London, Greater London, United Kingdom, SW170QT Norfolk and Norwich University Hospital | Norwich, Norfolk, United Kingdom, NR47UY Royal Shrewsbury Hospital | Shrewsbury, Shropshire, United Kingdom, SY3 8XQ University Hospital Coventry | Coventry, West Midlands, United Kingdom, CV2 2DX Royal Wolverhampton hospital | Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Investigators

More Information

Additional Information

• To obtain more information on the study, click here/on this link

Additional Relevant MeSH Terms

• Crohn Disease
• Colitis
• Colitis, Ulcerative
• Ulcer
• Inflammatory Bowel Diseases
• Gastroenteritis
• Gastrointestinal Diseases
• Digestive System Diseases
• Intestinal Diseases
• Colonic Diseases
• Pathologic Processes