Clinical trial NCT02611817: Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested to treat people who have moderate to severely active CD. This study will look at clinical remission, as well as enhanced clinical response and corticosteroid-free remission in participants with CD who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy.

The study will enroll approximately 824 participants. All participants will enter a 6 week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV infusion at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the two treatment groups:

* Vedolizumab SC 108 mg Maintenance Arm
* Placebo SC Maintenance Arm

Participants who do not achieve a clinical response will not be randomized into the Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at Week 6.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks. 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
2. 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).
3. CD involvement of the ileum and/or colon, at a minimum.
4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.

Exclusion Criteria:

1. Evidence of abdominal abscess at Screening.
2. Extensive colonic resection, subtotal or total colectomy.
3. History of \>3 small bowel resections or diagnosis of short bowel syndrome.
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
5. 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).
6. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
7. Prior exposure to vedolizumab.
8. Surgical intervention for CD required at any time during the study.
9. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
11. Active infections.
12. 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.
13. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Enhanced Clinical Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
timeFrame: Week 52
measure: Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Gastroenterology Associates
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: L & L Research Choices, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLL
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Lima
country: United States
facility: Gastro-Enterology Research of Lima
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: Milwaukee
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Tennyson Centre Day Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Kennedylaan
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Roeselare
country: Belgium
facility: AZ Delta
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Goiania
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
state: Goias
city: Rio de Janeiro
country: Brazil
facility: HUGG - Hospital Universitario Gaffree e Guinle
state: Rio Do Janeiro
city: Rio de Janeiro
country: Brazil
facility: HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
state: Rio Do Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericordia de Santos
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: Sao Paulo
city: Sliven
country: Bulgaria
facility: MHAT "Hadzhi Dimitar", OOD
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre - University of Alberta
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Brno
country: Czechia
facility: CCBR - Czech Brno, s.r.o..
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o.
city: Plzen
country: Czechia
facility: A-SHINE s.r.o.
city: Praha 3
country: Czechia
facility: CCBR Czech Prague, s.r.o.
city: Praha 5
country: Czechia
facility: Axon Clinical s.r.o.
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
state: Sachsen
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz-Rendelointezet
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: San Donato Milanese (MI)
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Milano
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliera Ospedale Cannizzaro
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba-Ken
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka-Ken
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo-Ken
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate-Ken
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa-Ken
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
state: Osaka-Fu
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga-Ken
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu South Hospital
state: Shizuoka-Ken
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo-To
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama-Ken
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Public Institution
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Leon
country: Mexico
facility: Centro de Investigacion Farmacologica del Bajio, S.C.
state: Guanajuato
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, Dordwijk
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
city: Lodz
country: Poland
facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Lublin
country: Poland
facility: GASTROMED Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Wroclaw
country: Poland
facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Krasnoyarsk
country: Russian Federation
facility: TSBIH "Territorial Clinical Hospital"
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Omsk
country: Russian Federation
facility: SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
city: Rostov-on-Don
country: Russian Federation
facility: SBEI HPE "Rostov State Medical University" of the MoH of the RF
city: Saint-Petersburg
country: Russian Federation
facility: LLC "RIAT SPb"
city: Sestroretsk
country: Russian Federation
facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"
city: St. Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"
city: Yaroslavl
country: Russian Federation
facility: SBIH of Yaroslavl region " Regional Clinical Hospital "
city: Belgrade
country: Serbia
facility: Clinical Helth Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
city: Pretoria
country: South Africa
facility: Dr CCM Ziady Practice
state: Gauteng
city: Cape Town
country: South Africa
facility: Dr JP Wright Practice
state: Western Cape
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset - Solna
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
city: Dnipro
country: Ukraine
facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
city: Kharkiv
country: Ukraine
facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
city: Kherson
country: Ukraine
facility: CI A.and O. Tropiny City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Odesa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
state: Devon
city: London
country: United Kingdom
facility: St George's Hospital
state: Greater London
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Greater London
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: Shropshire
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: West Midlands
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: