Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT02611817




Registration number
NCT02611817
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015

Titles & IDs
Public title
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Scientific 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
Secondary ID [1] 0 0
U1111-1168-0845
Secondary ID [2] 0 0
MLN0002SC-3031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab SC 108 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Vedolizumab IV 300 mg

Experimental: Vedolizumab SC 108 mg Maintenance Arm - Open-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 comparator: Placebo SC Maintenance Arm - Open-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


Treatment: Drugs: Vedolizumab SC 108 mg
Vedolizumab SC Injection.

Treatment: Drugs: Placebo
Vedolizumab placebo-matching SC injection.

Treatment: Drugs: Vedolizumab IV 300 mg
Vedolizumab IV Injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Timepoint [3] 0 0
Week 52

Eligibility
Key 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-a) antagonists.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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 administering the treatment/s
The people assessing the outcomes
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
4/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/08/2019
Sample size
Target
Accrual to date
Final
644
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Tennyson Centre Day Hospital - Bedford Park
Recruitment hospital [5] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3181 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Belgium
State/province [21] 0 0
Bonheiden
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Kortrijk
Country [24] 0 0
Belgium
State/province [24] 0 0
Merksem
Country [25] 0 0
Belgium
State/province [25] 0 0
Roeselare
Country [26] 0 0
Bosnia and Herzegovina
State/province [26] 0 0
Banja Luka
Country [27] 0 0
Bosnia and Herzegovina
State/province [27] 0 0
Mostar
Country [28] 0 0
Brazil
State/province [28] 0 0
Goias
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Do Janeiro
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sliven
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Sofia
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Hradec Kralove
Country [39] 0 0
Czechia
State/province [39] 0 0
Plzen
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 3
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 5
Country [42] 0 0
Denmark
State/province [42] 0 0
Odense C
Country [43] 0 0
Denmark
State/province [43] 0 0
Silkeborg
Country [44] 0 0
Estonia
State/province [44] 0 0
Tallinn
Country [45] 0 0
Germany
State/province [45] 0 0
Niedersachsen
Country [46] 0 0
Germany
State/province [46] 0 0
Rheinland Pfalz
Country [47] 0 0
Germany
State/province [47] 0 0
Sachsen
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Kistarcsa
Country [51] 0 0
Hungary
State/province [51] 0 0
Miskolc
Country [52] 0 0
Hungary
State/province [52] 0 0
Mosonmagyarovar
Country [53] 0 0
Hungary
State/province [53] 0 0
Szekesfehervar
Country [54] 0 0
Hungary
State/province [54] 0 0
Szekszard
Country [55] 0 0
Israel
State/province [55] 0 0
Afula
Country [56] 0 0
Israel
State/province [56] 0 0
Beer Sheva
Country [57] 0 0
Israel
State/province [57] 0 0
Jerusalem
Country [58] 0 0
Israel
State/province [58] 0 0
Ramat Gan
Country [59] 0 0
Israel
State/province [59] 0 0
Rechovot
Country [60] 0 0
Israel
State/province [60] 0 0
Tel Aviv
Country [61] 0 0
Italy
State/province [61] 0 0
Foggia
Country [62] 0 0
Italy
State/province [62] 0 0
Milano
Country [63] 0 0
Italy
State/province [63] 0 0
Bologna
Country [64] 0 0
Italy
State/province [64] 0 0
Catania
Country [65] 0 0
Italy
State/province [65] 0 0
Modena
Country [66] 0 0
Italy
State/province [66] 0 0
Padova
Country [67] 0 0
Italy
State/province [67] 0 0
Palermo
Country [68] 0 0
Italy
State/province [68] 0 0
Roma
Country [69] 0 0
Japan
State/province [69] 0 0
Chiba-Ken
Country [70] 0 0
Japan
State/province [70] 0 0
Fukuoka-Ken
Country [71] 0 0
Japan
State/province [71] 0 0
Hokkaido
Country [72] 0 0
Japan
State/province [72] 0 0
Hyogo-Ken
Country [73] 0 0
Japan
State/province [73] 0 0
Iwate-Ken
Country [74] 0 0
Japan
State/province [74] 0 0
Kanagawa-Ken
Country [75] 0 0
Japan
State/province [75] 0 0
Osaka-Fu
Country [76] 0 0
Japan
State/province [76] 0 0
Saga-Ken
Country [77] 0 0
Japan
State/province [77] 0 0
Shizuoka-Ken
Country [78] 0 0
Japan
State/province [78] 0 0
Tokyo-To
Country [79] 0 0
Japan
State/province [79] 0 0
Wakayama-Ken
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Daegu
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Seoul
Country [82] 0 0
Lithuania
State/province [82] 0 0
Kaunas
Country [83] 0 0
Lithuania
State/province [83] 0 0
Vilnius
Country [84] 0 0
Mexico
State/province [84] 0 0
Guanajuato
Country [85] 0 0
Mexico
State/province [85] 0 0
Durango
Country [86] 0 0
Mexico
State/province [86] 0 0
Veracruz
Country [87] 0 0
Netherlands
State/province [87] 0 0
Amsterdam
Country [88] 0 0
Netherlands
State/province [88] 0 0
Dordrecht
Country [89] 0 0
Netherlands
State/province [89] 0 0
Rotterdam
Country [90] 0 0
Poland
State/province [90] 0 0
Bydgoszcz
Country [91] 0 0
Poland
State/province [91] 0 0
Krakow
Country [92] 0 0
Poland
State/province [92] 0 0
Lodz
Country [93] 0 0
Poland
State/province [93] 0 0
Lublin
Country [94] 0 0
Poland
State/province [94] 0 0
Szczecin
Country [95] 0 0
Poland
State/province [95] 0 0
Warszawa
Country [96] 0 0
Poland
State/province [96] 0 0
Wroclaw
Country [97] 0 0
Romania
State/province [97] 0 0
Bucuresti
Country [98] 0 0
Romania
State/province [98] 0 0
Timisoara
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Kazan
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Krasnoyarsk
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Novosibirsk
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Omsk
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Rostov-on-Don
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Saint-Petersburg
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Sestroretsk
Country [106] 0 0
Russian Federation
State/province [106] 0 0
St. Petersburg
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Yaroslavl
Country [108] 0 0
Serbia
State/province [108] 0 0
Belgrade
Country [109] 0 0
Serbia
State/province [109] 0 0
Kragujevac
Country [110] 0 0
Serbia
State/province [110] 0 0
Novi Sad
Country [111] 0 0
Slovakia
State/province [111] 0 0
Banska Bystrica
Country [112] 0 0
Slovakia
State/province [112] 0 0
Bratislava
Country [113] 0 0
South Africa
State/province [113] 0 0
Gauteng
Country [114] 0 0
South Africa
State/province [114] 0 0
Western Cape
Country [115] 0 0
Sweden
State/province [115] 0 0
Stockholm
Country [116] 0 0
Taiwan
State/province [116] 0 0
Taipei
Country [117] 0 0
Turkey
State/province [117] 0 0
Ankara
Country [118] 0 0
Turkey
State/province [118] 0 0
Istanbul
Country [119] 0 0
Turkey
State/province [119] 0 0
Kocaeli
Country [120] 0 0
Turkey
State/province [120] 0 0
Mersin
Country [121] 0 0
Ukraine
State/province [121] 0 0
Chernivtsi
Country [122] 0 0
Ukraine
State/province [122] 0 0
Dnipro
Country [123] 0 0
Ukraine
State/province [123] 0 0
Kharkiv
Country [124] 0 0
Ukraine
State/province [124] 0 0
Kherson
Country [125] 0 0
Ukraine
State/province [125] 0 0
Kyiv
Country [126] 0 0
Ukraine
State/province [126] 0 0
Lviv
Country [127] 0 0
Ukraine
State/province [127] 0 0
Odesa
Country [128] 0 0
Ukraine
State/province [128] 0 0
Ternopil
Country [129] 0 0
Ukraine
State/province [129] 0 0
Vinnytsia
Country [130] 0 0
Ukraine
State/province [130] 0 0
Zaporizhzhia
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Devon
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Greater London
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Shropshire
Country [134] 0 0
United Kingdom
State/province [134] 0 0
West Midlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02611817