Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02497469




Registration number
NCT02497469
Ethics application status
Date submitted
10/07/2015
Date registered
14/07/2015
Date last updated
28/01/2020

Titles & IDs
Public title
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Scientific title
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
U1111-1168-6713
Secondary ID [2] 0 0
MLN0002-3026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab
Treatment: Drugs - Adalimumab placebo
Treatment: Drugs - Adalimumab
Treatment: Drugs - Vedolizumab placebo

Experimental: Vedolizumab IV 300 mg - Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.

Active comparator: Adalimumab SC 160/80/40 mg - Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.


Treatment: Drugs: Vedolizumab
Vedolizumab infusion

Treatment: Drugs: Adalimumab placebo
Adalimumab placebo-matching injection

Treatment: Drugs: Adalimumab
Adalimumab injection

Treatment: Drugs: Vedolizumab placebo
Vedolizumab placebo-matching infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Mucosal Healing
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
Timepoint [2] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
4. With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
5. The participant:

1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (example, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponders]), or
2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.
2. Has had an extensive colonic resection, subtotal or total colectomy.
3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
5. Has received any of the following for the treatment of underlying disease within 30 days of randomization:

1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
2. An approved non-biologic therapy in an investigational protocol.
6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
8. Has previously received vedolizumab.
9. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
10. Evidence of an active infection during Screening.
11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg], may participate).
13. Has active or latent TB, regardless of treatment history.
14. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2019
Sample size
Target
Accrual to date
Final
771
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Tennyson Centre Day Hospital - Bedford Park
Recruitment hospital [6] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [7] 0 0
Monash Medical Centre Moorabbin - Clayton
Recruitment hospital [8] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3350 - Ballarat
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Ciudad Autonoma Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Cordoba
Country [37] 0 0
Belgium
State/province [37] 0 0
Gent
Country [38] 0 0
Bosnia and Herzegovina
State/province [38] 0 0
Banja Luka
Country [39] 0 0
Bosnia and Herzegovina
State/province [39] 0 0
Mostar
Country [40] 0 0
Bosnia and Herzegovina
State/province [40] 0 0
Sarajevo
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Pazardzhik
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Pleven
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Sliven
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Sofia
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Stara Zagora
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Varna
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Saskatchewan
Country [50] 0 0
Colombia
State/province [50] 0 0
Floridablanca
Country [51] 0 0
Colombia
State/province [51] 0 0
Medellin
Country [52] 0 0
Croatia
State/province [52] 0 0
Osijek
Country [53] 0 0
Croatia
State/province [53] 0 0
Pula
Country [54] 0 0
Croatia
State/province [54] 0 0
Rijeka
Country [55] 0 0
Croatia
State/province [55] 0 0
Zagreb
Country [56] 0 0
Czechia
State/province [56] 0 0
Brno
Country [57] 0 0
Czechia
State/province [57] 0 0
Hradec Kralove
Country [58] 0 0
Czechia
State/province [58] 0 0
Pardubice
Country [59] 0 0
Czechia
State/province [59] 0 0
Plzen
Country [60] 0 0
Czechia
State/province [60] 0 0
Praha 3
Country [61] 0 0
Czechia
State/province [61] 0 0
Praha 4 - Krc
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha 7
Country [63] 0 0
Czechia
State/province [63] 0 0
Praha 8
Country [64] 0 0
Denmark
State/province [64] 0 0
Frederikssund
Country [65] 0 0
Denmark
State/province [65] 0 0
Hvidovre
Country [66] 0 0
Denmark
State/province [66] 0 0
Koge
Country [67] 0 0
Denmark
State/province [67] 0 0
Odense C
Country [68] 0 0
Estonia
State/province [68] 0 0
Tallinn
Country [69] 0 0
Estonia
State/province [69] 0 0
Tartu
Country [70] 0 0
France
State/province [70] 0 0
Alpes Maritimes
Country [71] 0 0
France
State/province [71] 0 0
Bouches-du-Rhone
Country [72] 0 0
France
State/province [72] 0 0
Gironde
Country [73] 0 0
France
State/province [73] 0 0
Haute Garonne
Country [74] 0 0
France
State/province [74] 0 0
Hauts De Seine
Country [75] 0 0
France
State/province [75] 0 0
Loire
Country [76] 0 0
France
State/province [76] 0 0
Meurthe Et Moselle
Country [77] 0 0
France
State/province [77] 0 0
Nord
Country [78] 0 0
France
State/province [78] 0 0
Somme
Country [79] 0 0
France
State/province [79] 0 0
Vendee
Country [80] 0 0
Germany
State/province [80] 0 0
Baden Wuerttemberg
Country [81] 0 0
Germany
State/province [81] 0 0
Hessen
Country [82] 0 0
Germany
State/province [82] 0 0
Nordrhein Westfalen
Country [83] 0 0
Germany
State/province [83] 0 0
Rheinland Pfalz
Country [84] 0 0
Germany
State/province [84] 0 0
Sachsen Anhalt
Country [85] 0 0
Germany
State/province [85] 0 0
Sachsen
Country [86] 0 0
Germany
State/province [86] 0 0
Schleswig Holstein
Country [87] 0 0
Germany
State/province [87] 0 0
Berlin
Country [88] 0 0
Germany
State/province [88] 0 0
Hamburg
Country [89] 0 0
Hong Kong
State/province [89] 0 0
Hong Kong
Country [90] 0 0
Hong Kong
State/province [90] 0 0
Medicine & Geriatrics
Country [91] 0 0
Hong Kong
State/province [91] 0 0
Shatin
Country [92] 0 0
Hungary
State/province [92] 0 0
Bekescsaba
Country [93] 0 0
Hungary
State/province [93] 0 0
Budapest
Country [94] 0 0
Hungary
State/province [94] 0 0
Debrecen
Country [95] 0 0
Hungary
State/province [95] 0 0
Eger
Country [96] 0 0
Hungary
State/province [96] 0 0
Pecs
Country [97] 0 0
Hungary
State/province [97] 0 0
Szeged
Country [98] 0 0
Hungary
State/province [98] 0 0
Szekszard
Country [99] 0 0
Israel
State/province [99] 0 0
Afula
Country [100] 0 0
Israel
State/province [100] 0 0
Ashkelon
Country [101] 0 0
Israel
State/province [101] 0 0
Hadera
Country [102] 0 0
Israel
State/province [102] 0 0
Holon
Country [103] 0 0
Israel
State/province [103] 0 0
Jerusalem
Country [104] 0 0
Israel
State/province [104] 0 0
Kfar- Saba
Country [105] 0 0
Israel
State/province [105] 0 0
Nahariya
Country [106] 0 0
Israel
State/province [106] 0 0
Ramat Gan
Country [107] 0 0
Israel
State/province [107] 0 0
Rechovot
Country [108] 0 0
Israel
State/province [108] 0 0
Tel Aviv
Country [109] 0 0
Italy
State/province [109] 0 0
Foggia
Country [110] 0 0
Italy
State/province [110] 0 0
Milano
Country [111] 0 0
Italy
State/province [111] 0 0
Bologna
Country [112] 0 0
Italy
State/province [112] 0 0
Catania
Country [113] 0 0
Italy
State/province [113] 0 0
Genova
Country [114] 0 0
Italy
State/province [114] 0 0
Messina
Country [115] 0 0
Italy
State/province [115] 0 0
Modena
Country [116] 0 0
Italy
State/province [116] 0 0
Napoli
Country [117] 0 0
Italy
State/province [117] 0 0
Padova
Country [118] 0 0
Italy
State/province [118] 0 0
Palermo
Country [119] 0 0
Italy
State/province [119] 0 0
Pisa
Country [120] 0 0
Italy
State/province [120] 0 0
Roma
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Gyeonggi-do
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Gyeongsangbuk-do
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Busan
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Daegu
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Latvia
State/province [126] 0 0
Riga
Country [127] 0 0
Lithuania
State/province [127] 0 0
Kaunas
Country [128] 0 0
Lithuania
State/province [128] 0 0
Klaipeda
Country [129] 0 0
Lithuania
State/province [129] 0 0
Vilnius
Country [130] 0 0
Mexico
State/province [130] 0 0
Guanajuato
Country [131] 0 0
Mexico
State/province [131] 0 0
Nuevo Leon
Country [132] 0 0
Mexico
State/province [132] 0 0
Durango
Country [133] 0 0
Mexico
State/province [133] 0 0
Veracruz
Country [134] 0 0
Netherlands
State/province [134] 0 0
Amsterdam
Country [135] 0 0
Netherlands
State/province [135] 0 0
Groningen
Country [136] 0 0
Netherlands
State/province [136] 0 0
Maastricht
Country [137] 0 0
Netherlands
State/province [137] 0 0
Rotterdam
Country [138] 0 0
Poland
State/province [138] 0 0
Bialystok
Country [139] 0 0
Poland
State/province [139] 0 0
Bydgoszcz
Country [140] 0 0
Poland
State/province [140] 0 0
Gdansk
Country [141] 0 0
Poland
State/province [141] 0 0
Katowice
Country [142] 0 0
Poland
State/province [142] 0 0
Krakow
Country [143] 0 0
Poland
State/province [143] 0 0
Lodz
Country [144] 0 0
Poland
State/province [144] 0 0
Lublin
Country [145] 0 0
Poland
State/province [145] 0 0
Poznan
Country [146] 0 0
Poland
State/province [146] 0 0
Szczecin
Country [147] 0 0
Poland
State/province [147] 0 0
Warszawa
Country [148] 0 0
Poland
State/province [148] 0 0
Wroclaw
Country [149] 0 0
Portugal
State/province [149] 0 0
Braga
Country [150] 0 0
Portugal
State/province [150] 0 0
Coimbra
Country [151] 0 0
Portugal
State/province [151] 0 0
Covilha
Country [152] 0 0
Portugal
State/province [152] 0 0
Guimaraes
Country [153] 0 0
Portugal
State/province [153] 0 0
Viana do Castelo
Country [154] 0 0
Portugal
State/province [154] 0 0
Vila Nova de Gaia
Country [155] 0 0
Romania
State/province [155] 0 0
Bucuresti
Country [156] 0 0
Romania
State/province [156] 0 0
Timisoara
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Kazan
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Krasnoyarsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Moscow
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Nizhny Novgorod
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Novosibirsk
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Omsk
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Rostov-on-Don
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Saint-Petersburg
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Samara
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Saratov
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Sestroretsk
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Smolensk
Country [169] 0 0
Russian Federation
State/province [169] 0 0
St. Petersburg
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Yaroslavl
Country [171] 0 0
Serbia
State/province [171] 0 0
Belgrade
Country [172] 0 0
Serbia
State/province [172] 0 0
Kragujevac
Country [173] 0 0
Serbia
State/province [173] 0 0
Nis
Country [174] 0 0
Serbia
State/province [174] 0 0
Novi Sad
Country [175] 0 0
Slovakia
State/province [175] 0 0
Bratislava
Country [176] 0 0
Slovakia
State/province [176] 0 0
Kosice
Country [177] 0 0
Slovakia
State/province [177] 0 0
Nitra
Country [178] 0 0
Slovakia
State/province [178] 0 0
Presov
Country [179] 0 0
Slovakia
State/province [179] 0 0
Sahy
Country [180] 0 0
Spain
State/province [180] 0 0
Barcelona
Country [181] 0 0
Spain
State/province [181] 0 0
Madrid
Country [182] 0 0
Spain
State/province [182] 0 0
Alicante
Country [183] 0 0
Taiwan
State/province [183] 0 0
Kaohsiung
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taichung
Country [185] 0 0
Taiwan
State/province [185] 0 0
Taipei
Country [186] 0 0
Turkey
State/province [186] 0 0
Ankara
Country [187] 0 0
Turkey
State/province [187] 0 0
Istanbul
Country [188] 0 0
Turkey
State/province [188] 0 0
Kocaeli
Country [189] 0 0
Turkey
State/province [189] 0 0
Mersin
Country [190] 0 0
Ukraine
State/province [190] 0 0
Chernivtsi
Country [191] 0 0
Ukraine
State/province [191] 0 0
Dnipropetrovsk
Country [192] 0 0
Ukraine
State/province [192] 0 0
Ivano-Frankivsk
Country [193] 0 0
Ukraine
State/province [193] 0 0
Kharkiv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Kherson
Country [195] 0 0
Ukraine
State/province [195] 0 0
Kirovohrad
Country [196] 0 0
Ukraine
State/province [196] 0 0
Kyiv
Country [197] 0 0
Ukraine
State/province [197] 0 0
Lviv
Country [198] 0 0
Ukraine
State/province [198] 0 0
Odesa
Country [199] 0 0
Ukraine
State/province [199] 0 0
Uzhgorod
Country [200] 0 0
Ukraine
State/province [200] 0 0
Vinnytsia
Country [201] 0 0
Ukraine
State/province [201] 0 0
Zaporizhzhia
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Devon
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Greater Manchester
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Norfolk
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Strathclyde
Country [206] 0 0
United Kingdom
State/province [206] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
Trial website
https://clinicaltrials.gov/study/NCT02497469
Trial related presentations / publications
Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.
Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02497469