Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
10 other identifiers
interventional
644
29 countries
189
Brief Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Typical duration for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedStudy Start
First participant enrolled
January 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2019
CompletedResults Posted
Study results publicly available
June 23, 2020
CompletedMay 25, 2022
May 1, 2022
3.3 years
November 19, 2015
May 5, 2020
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (\<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Week 52
Secondary Outcomes (3)
Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Week 52
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Week 52
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Week 52
Study Arms (2)
Vedolizumab SC 108 mg Maintenance Arm
EXPERIMENTALOpen-label Induction: vedolizumab IV 300 milligram (mg), infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Placebo SC Maintenance Arm
PLACEBO COMPARATOROpen-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Interventions
Vedolizumab IV Injection.
Eligibility Criteria
You may qualify if:
- Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
- Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of the following:
- C-reactive protein (CRP) level greater than (\>) 2.87 milligram per liter (mg/L) OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each \>0.5 centimeter \[cm\] in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
- Fecal calprotectin \>250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
- CD involvement of the ileum and/or colon, at a minimum.
- Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.
You may not qualify if:
- Evidence of abdominal abscess at Screening.
- Extensive colonic resection, subtotal or total colectomy.
- History of \>3 small bowel resections or diagnosis of short bowel syndrome.
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to vedolizumab.
- Surgical intervention for CD required at any time during the study.
- History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
- Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Active infections.
- Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (that is, being hepatitis B surface antigen \[HBsAg\] negative and hepatitis B antibody positive) may, however, be included.
- History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (194)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 45806, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 11021, United States
Middlesex Gastroenterology Associates
Middletown, Connecticut, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 55905, United States
L & L Research Choices, Inc.
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, 30342, United States
Shafran Gastroenterology Center
Winter Park, Florida, 70809, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 33176, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 53226, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 48047, United States
Grand Teton Research Group, PLL
Idaho Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, 33028, United States
Carle Foundation Hospital
Urbana, Illinois, 74104, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 06518, United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 06457, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 85307, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 32789, United States
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 49519, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 34102, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 30024, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 60612, United States
Long Island Clinical Research Associates
Great Neck, New York, 71105, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 41017, United States
Gastro-Enterology Research of Lima
Lima, Ohio, 39581, United States
Options Health Research
Tulsa, Oklahoma, 83404, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 78212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 61801, United States
San Antonio Gastroenterology
San Antonio, Texas, United States
Allegiance Research Specialists, LLC
Milwaukee, Wisconsin, 64012, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Tennyson Centre Day Hospital
Bedford Park, South Australia, 5042, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3181, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Groeninge - Kennedylaan
Kortrijk, 8500, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
AZ Delta
Roeselare, 8800, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, 88000, Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
HUGG - Hospital Universitario Gaffree e Guinle
Rio de Janeiro, Rio Do Janeiro, 20270-004, Brazil
HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio Do Janeiro, 21941-913, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, 11075-900, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800, Bulgaria
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
Zeidler Ledcor Centre - University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3M9, Canada
LHSC - University Hospital
London, Ontario, N6A 5A5, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
CCBR - Czech Brno, s.r.o..
Brno, 60200, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, 500 12, Czechia
A-SHINE s.r.o.
Pilsen, 31200, Czechia
CCBR Czech Prague, s.r.o.
Prague, 13000, Czechia
Axon Clinical s.r.o.
Prague, 15000, Czechia
Odense Universitetshospital
Odense C, 5000, Denmark
Regionshospitalet Silkeborg
Silkeborg, 8600, Denmark
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
EUGASTRO GmbH
Leipzig, Saxony, 04103, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Karolina Korhaz-Rendelointezet
Mosonmagyaróvár, H-9200, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
HaEmek Medical Center
Afula, 18101, Israel
Soroka University Medical Center
Beersheba, 8410101, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Milano, 20097, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Ospedale Cannizzaro
Catania, 95100, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Toho University Sakura Medical Center
Sakura-shi, Chiba, 285-8741, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-0033, Japan
Tokushukai Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056, Japan
Kinshukai Infusion Clinic
Osaka, Osaka, 530-0011, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
Hamamatsu South Hospital
Hamamatsu, Shizuoka, 430-0846, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Tokyo-To, 108-8642, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo-To, 169-0073, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, LT-08661, Lithuania
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, 37000, Mexico
Centro de Investigacion Farmacologica del Bajio, S.C.
León, Guanajuato, 37520, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91910, Mexico
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, 3318 AT, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
Lodz, 90-153, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
GASTROMED Sp. z o.o.
Lublin, 20-582, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-270, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333, Poland
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
Kazan State Medical University
Kazan', 420012, Russia
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, 660022, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630091, Russia
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
Novosibirsk, 630117, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
Omsk, 644099, Russia
SBEI HPE "Rostov State Medical University" of the MoH of the RF
Rostov-on-Don, 344022, Russia
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
Saint Petersburg, 195257, Russia
LLC "RIAT SPb"
Saint Petersburg, 197373, Russia
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Sestroretsk, 197706, Russia
SBIH of Yaroslavl region " Regional Clinical Hospital "
Yaroslavl, 150062, Russia
Clinical Helth Centre Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center Bezanijska kosa
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Dr CCM Ziady Practice
Pretoria, Gauteng, 0181, South Africa
Dr JP Wright Practice
Cape Town, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Karolinska Universitetssjukhuset - Solna
Stockholm, 11490, Sweden
Mackay Memorial Hospital
Taipei, 100, Taiwan
Ankara University Medical Faculty
Ankara, 41380, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, 01023, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 33343, Turkey (Türkiye)
Kocaeli Derince Training and Research Hospital
Kocaeli, 34668, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 34098, Turkey (Türkiye)
RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
Chernivtsi, 21005, Ukraine
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipro, 69104, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, 58002, Ukraine
CI A.and O. Tropiny City Clinical Hospital
Kherson, 79059, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, 46002, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, 49074, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, 65025, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, 01103, Ukraine
CI Odesa Regional Clinical Hospital
Odesa, 21009, Ukraine
Ternopil University Hospital
Ternopil, CV2 2DX, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 01023, Ukraine
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21001, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 73000, Ukraine
CI City Hospital #1
Zaporizhzhia, EX2 5DW, Ukraine
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, SY3 8XQ, United Kingdom
St George's Hospital
London, Greater London, 31201, United Kingdom
Whipps Cross University Hospital
London, Greater London, SW170QT, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, 34452, United Kingdom
University Hospital Coventry
Coventry, West Midlands, NW3 2QG, United Kingdom
Related Publications (1)
D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV Jr, Sandborn WJ, Dornic Q, Lindner D, Kisfalvi K, Marins EG, Vermeire S. Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.
PMID: 38417060DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 23, 2015
Study Start
January 4, 2016
Primary Completion
May 6, 2019
Study Completion
August 6, 2019
Last Updated
May 25, 2022
Results First Posted
June 23, 2020
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.