Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom 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.

Study Overview

• Status: Terminated
• Conditions: Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: Vedolizumab

Detailed Description

The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab.

Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive:

• Vedolizumab 300 mg

All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Box Hill Hospital
  • Herston, Australia, 4029
    • Royal Brisbane & Women's Hospital
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • The Canberra Hospital
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Western Hospital
    • Malvern, Victoria, Australia, 3144
      • Cabrini Medical Centre
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Multiprofile Hospital For Active Treatment Ruse
  • Sofia, Bulgaria, 1784
    • City Clinic University Multiprofile Hospital for Active Treatment EOOD
• Czechia
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s. r. o.
  • Kladno, Czechia, 272 01
    • Oblastní nemocnice Kladno, a.s.
  • Pardubice, Czechia, 532 03
    • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 4, Czechia, 140 21
    • Institut Klinicke a Experimentalni Mediciny
  • Praha 7, Czechia, 170 00
    • ISCARE I.V.F. a.s.
  • Strakonice, Czechia, 386 29
    • Nemocnice Strakonice, a.s.
  • Tabor, Czechia, 390 03
    • Nemocnice Tabor, a.s.
  • Usti Nad Labem, Czechia, 401 13
    • Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
  • Karlovarsk Kraj
    • Karlovy Vary, Karlovarsk Kraj, Czechia, 360 66
      • Karlovarska krajska nemocnice a.s.
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tallinn, Estonia, EE-10138
    • East Tallinn Central Hospital
• Hungary
  • Bekescsaba, Hungary, 5600
    • Békés Megyei Központi Kórház
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1076
    • Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
  • Dunaujvaros, Hungary, 2400
    • Szent Pantaleon Korhaz-Rendelointezet
  • Gyongyos, Hungary, 3200
    • Bugát Pál Kórház
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház
  • Mosonmagyarovar, Hungary, 9200
    • Karolina Korhaz Rendelointezet
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Korhaz
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem
  • Szekesfehervar, Hungary, 8000
    • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa Janos Korhaz
  • Csongrad
    • Szeged, Csongrad, Hungary, 6720
      • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500058
      • Owaisi Hospital and Research Centre
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences
  • Kerala
    • Kochi, Kerala, India, 682304
      • Lakeshore Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411011
      • KEM Hospital Research Centre
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641005
      • VGM Hospital Institute of Gastroenterology
• Italy
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Policlínico San Donato
• Korea, Republic of
  • Daegu, Korea, Republic of, 705-703
    • Yeungnam University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital Yonsei University Health System - PPDS
  • Seoul, Korea, Republic of, 130-702
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center - PPDS
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center - PPDS
• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• New Zealand
  • Auckland, New Zealand, 620
    • Shakespeare Specialist Group
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital
  • Waikato
    • Hamilton, Waikato, New Zealand, 3240
      • Waikato Hospital
• Poland
  • Bialystok, Poland, 15-950
    • SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
  • Bydgoszcz, Poland, 85-681
    • 10 Wojskowy Szpital Kliniczny z Polikliniką
  • Gliwice, Poland, 44-122
    • Corpora-Med
  • Warsaw, Poland, 00-632
    • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW
  • Wroclaw, Poland, 50556
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 53-333
      • ARS Médica
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-531
      • Sp Zoz Szpital Uniwersytecki W Krakowie
    • Krakow, Malopolskie, Poland, 31-826
      • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Slaskie
    • Czestochowa, Slaskie, Poland, 42-202
      • Centrum Medyczne sw. Lukasza
• Romania
  • Bucharest, Romania, 22322
    • Fundeni Clinical Institute
  • Bucuresti, Romania, 20125
    • Colentina Clinical Hospital
• Russian Federation
  • Moscow, Russian Federation, 125005
    • City Clinical Hospital #24
  • Nizhniy Novgorod, Russian Federation, 603126
    • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
  • Saint Petersburg, Russian Federation, 191015
    • Russian Medical Military Academy n.a. S.M. Kirov
  • Samara, Russian Federation, 443093
    • Medical Company Hepatolog, LLC
  • St. Petersburg, Russian Federation, 191119
    • Union Clinic, LLC
  • St. Petersburg, Russian Federation, 194354
    • St.Petersburg Multi Field City Hospital #2
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
• South Africa
  • Bloemfontein, South Africa, 9301
    • Universitas Hospital
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1619
      • CLINRESCO, ARWYP Medical Suites
  • Kwazulu - Natal
    • Durban, Kwazulu - Natal, South Africa, 4001
      • St Augustines Medical Centre
  • Western Cape
    • Claremont, Western Cape, South Africa, 7708
      • Kingsbury Hospital
• Turkey
  • Istanbul, Turkey, 34890
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
• Ukraine
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
  • Vinnyts'ka Oblast
    • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21029
      • Medical Clinical Research Center of Medical Center LLC Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Vedolizumab; Vedolizumab IV infusion; Other Names: Entyvio; MLN0002; Kynteles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.	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)
Percentage of Participants With Adverse Events of Special Interest (AESIs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy [PML]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.	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)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda

Publications and helpful links

General Publications

• Danese S, Subramaniam K, Van Zyl J, Adsul S, Lindner D, Roth J, Vermeire S. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.

Helpful Links

• To obtain more information about this study, click this link.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimated): April 19, 2016

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: Vedolizumab-4013; 2016-000678-40 (EudraCT Number); U1111-1180-9339 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes