Trial from ClinicalTrials.gov

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Trial ID
NCT02394028
Ethics application status
Date submitted
27/02/2015
Date registered
27/02/2015
Date last updated
9/03/2017

Titles & IDs
Public title
A Study of the Safety and Efficacy of Etrolizumab in Patients With Moderately to Severely Active Crohn's Disease
Scientific title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
Secondary ID [1] 0 0
2014-003824-36
Secondary ID [2] 0 0
GA29144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn 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 - Etrolizumab 210 mg
Treatment: drugs - Etrolizumab 105 mg
Treatment: drugs - Placebo

Experimental: Etrolizumab 105 mg Q4W in Induction and Maintenance Arms -

Experimental: Etrolizumab 210 mg Weeks 0,2,4,8 and 12 in Induction Arm only -

Placebo Comparator: Placebo -


Treatment: drugs: Etrolizumab 210 mg
Induction phase only: 210 mg dose subcutaneous injection administration at Weeks 0,2,4,8 and 12

Treatment: drugs: Etrolizumab 105 mg
Induction Phase : 105 mg dose subcutaneous administration at Weeks 0,4,8 and 12; Maintenance Phase : Single 105 mg dose subcutaneous administration Q4W

Treatment: drugs: Placebo
Matching placebo to either etrolizumab 105 mg or etrolizumab 210 mg according to the treatment schedule

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maintenance of clinical remission (as determined by PRO2 score) at Week 66 (US)
Timepoint [1] 0 0
At Week 66
Primary outcome [2] 0 0
Induction Phase: Clinical remission as determined by the Crohn's Disease Activity Index (CDAI) score (ex-US)
Timepoint [2] 0 0
At Week 14
Primary outcome [3] 0 0
Maintenance of clinical remission (as determined by CDAI score) after at least 52 weeks and corticosteroid-free for at least 52 weeks (ex-US)
Timepoint [3] 0 0
52 weeks
Primary outcome [4] 0 0
Induction Phase: Clinical remission as determined by the 2 Item Patient Reported Outcome (PRO2) score (US)
Timepoint [4] 0 0
At Week 14
Secondary outcome [1] 0 0
Safety (composite outcome measure): Incidence and severity of adverse events; incidence of anti-therapeutic antibodies to etrolizumab
Timepoint [1] 0 0
Up to 90 weeks
Secondary outcome [2] 0 0
Proportion of patients who achieve 100 points reduction in their CDAI score (CDAI-100 response)
Timepoint [2] 0 0
At Week 14
Secondary outcome [3] 0 0
Maintenance Phase: Proportion of patients who achieve CDAI-100 response
Timepoint [3] 0 0
At Week 66

Eligibility
Key inclusion criteria
- 18-80 years of age (inclusive)

- Moderately to severely active Crohn's disease as determined by the Crohn's Disease
Activity Index (CDAI), patient reported outcomes and endoscopically defined disease
activity in the ileum and/or colon

- Intolerance, loss of response or failure to respond to corticosteroids (CS) or,
immunosuppressants (IS), or TNF inhibitors within the previous 5 years

- Use of effective contraception as defined by the protocol
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A history of, or current conditions affecting the digestive tract, such as ulcerative
colitis, indeterminant colitis, fistulizing disease, abdominal or perianal abscess,
adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel
syndrome

- Planned surgery for CD

- Ileostomy or colostomy

- Has received non-permitted inflammatory bowel disease (IBD) therapies (including
natalizumab, vedolizumab, and efilizumab, as stated in the protocol)

- Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with
prior history of BCG vaccination must pass protocol-defined screening criteria)

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Launceston General Hospital; Gastroenterology Research - Launceston
Recruitment hospital [8] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [9] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [10] 0 0
Footscray Hospital; Gastroenterology - Footscray
Recruitment hospital [11] 0 0
Emeritus Research - Malvern East
Recruitment hospital [12] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [13] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Garran
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
7250 - Launceston
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3011 - Footscray
Recruitment postcode(s) [11] 0 0
3145 - Malvern East
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment outside Australia
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Argentina
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Cordoba
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Quilmes
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Rosario
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Innsbruck
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Austria
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Gent
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Sofia
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Varna
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Osijek
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Pardubice
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Praha 5
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Czech Republic
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Praha
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Czech Republic
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Usi nad Orlici
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Estonia
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Tallinn
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Estonia
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Tartu
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Amiens
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Clichy cedex
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Lille
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Nantes
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Pessac
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Rennes cedex 09
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Berlin
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Bochum
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Dresden
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Essen
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Frankfurt
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Halle (Saale)
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Germany
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Halle
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Jena
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Kiel
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Germany
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Koeln
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Lueneburg
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Lübeck
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Mannheim
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Germany
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Muenster
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Germany
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Munchen
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Germany
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Neustadt
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Germany
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Offenburg
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Germany
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Ulm
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Budapest
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Debrecen
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Eger
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Gyula
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Kistarcsa
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Miskolc
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Pecs
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Beer Yaacov
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Israel
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Holon
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Jerusalem
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Israel
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Nazareth
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Israel
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Petach Tikva
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Israel
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Rechovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Toscana
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Gyeonggi-do
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Seoul
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Suwon-si,
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Wonju-Si
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Latvia
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Riga
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Morelia
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Leiden
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Maastricht
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Rotterdam
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Hamilton
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Lower Hutt
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Takapuna
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New Zealand
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Tauranga
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Poland
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Elblag
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Gdansk
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Lodz
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Sopot
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Wroclaw
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Romania
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Bucharest
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Romania
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Timisoara
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Russian Federation
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Leningrad
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Russian Federation
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Barnaul
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Russian Federation
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Irkutsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Pushkin
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Ulyanovsk
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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NIS
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Nove Mesto nad Vahom
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Slovakia
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Sahy
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
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Sevilla
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Spain
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Zaragoza
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Bern
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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Turkey
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the
safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to
severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF)
naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor
inhibitors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GA29144 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global.rochegenentechtrials@roche.com
Contact person for scientific queries
Contact person responsible for updating information