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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02743806




Registration number
NCT02743806
Ethics application status
Date submitted
15/04/2016
Date registered
19/04/2016

Titles & IDs
Public title
Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Scientific title
Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
Secondary ID [1] 0 0
2016-000678-40
Secondary ID [2] 0 0
Vedolizumab-4013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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

Experimental: Vedolizumab 300 mg - Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.


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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Timepoint [2] 0 0
From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)

Eligibility
Key inclusion criteria
1. Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
2. In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
4. A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
2. Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
3. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
4. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/01/2023
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Western Hospital - Footscray
Recruitment hospital [3] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Ruse
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Czechia
State/province [3] 0 0
Karlovarsk Kraj
Country [4] 0 0
Czechia
State/province [4] 0 0
Hradec Kralove
Country [5] 0 0
Czechia
State/province [5] 0 0
Kladno
Country [6] 0 0
Czechia
State/province [6] 0 0
Pardubice
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 10
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 4
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 7
Country [10] 0 0
Czechia
State/province [10] 0 0
Strakonice
Country [11] 0 0
Czechia
State/province [11] 0 0
Tabor
Country [12] 0 0
Czechia
State/province [12] 0 0
Usti Nad Labem
Country [13] 0 0
Estonia
State/province [13] 0 0
Tallinn
Country [14] 0 0
Hungary
State/province [14] 0 0
Csongrad
Country [15] 0 0
Hungary
State/province [15] 0 0
Bekescsaba
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Dunaujvaros
Country [18] 0 0
Hungary
State/province [18] 0 0
Gyongyos
Country [19] 0 0
Hungary
State/province [19] 0 0
Gyula
Country [20] 0 0
Hungary
State/province [20] 0 0
Kaposvar
Country [21] 0 0
Hungary
State/province [21] 0 0
Mosonmagyarovar
Country [22] 0 0
Hungary
State/province [22] 0 0
Nagykanizsa
Country [23] 0 0
Hungary
State/province [23] 0 0
Pecs
Country [24] 0 0
Hungary
State/province [24] 0 0
Szekesfehervar
Country [25] 0 0
Hungary
State/province [25] 0 0
Szekszard
Country [26] 0 0
India
State/province [26] 0 0
Andhra Pradesh
Country [27] 0 0
India
State/province [27] 0 0
Delhi
Country [28] 0 0
India
State/province [28] 0 0
Kerala
Country [29] 0 0
India
State/province [29] 0 0
Maharashtra
Country [30] 0 0
India
State/province [30] 0 0
Tamil Nadu
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Rozzano
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Latvia
State/province [35] 0 0
Riga
Country [36] 0 0
Malaysia
State/province [36] 0 0
Kuala Lumpur
Country [37] 0 0
New Zealand
State/province [37] 0 0
Canterbury
Country [38] 0 0
New Zealand
State/province [38] 0 0
Waikato
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland
Country [40] 0 0
Poland
State/province [40] 0 0
Dolnoslaskie
Country [41] 0 0
Poland
State/province [41] 0 0
Malopolskie
Country [42] 0 0
Poland
State/province [42] 0 0
Slaskie
Country [43] 0 0
Poland
State/province [43] 0 0
Bialystok
Country [44] 0 0
Poland
State/province [44] 0 0
Bydgoszcz
Country [45] 0 0
Poland
State/province [45] 0 0
Gliwice
Country [46] 0 0
Poland
State/province [46] 0 0
Warsaw
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Romania
State/province [49] 0 0
Bucharest
Country [50] 0 0
Romania
State/province [50] 0 0
Bucuresti
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Nizhniy Novgorod
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Saint Petersburg
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Samara
Country [55] 0 0
Russian Federation
State/province [55] 0 0
St. Petersburg
Country [56] 0 0
Serbia
State/province [56] 0 0
Belgrade
Country [57] 0 0
South Africa
State/province [57] 0 0
Gauteng
Country [58] 0 0
South Africa
State/province [58] 0 0
Kwazulu - Natal
Country [59] 0 0
South Africa
State/province [59] 0 0
Western Cape
Country [60] 0 0
South Africa
State/province [60] 0 0
Bloemfontein
Country [61] 0 0
Turkey
State/province [61] 0 0
Istanbul
Country [62] 0 0
Ukraine
State/province [62] 0 0
Vinnyts'ka Oblast
Country [63] 0 0
Ukraine
State/province [63] 0 0
Poltava

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
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 makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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/NCT02743806