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Trial record 3 of 49 for:    vedolizumab

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02743806
First received: April 15, 2016
Last updated: November 21, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects 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 subject may be expected to develop worsening of disease if they were to modify treatment.

Condition Intervention Phase
Colitis, Ulcerative
Crohn Disease
Drug: Vedolizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From enrolment until the time the subject exits the study (up to 3 years) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From enrolment until the time the subject exits the study (up to 3 years) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: November 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks until vedolizumab is commercially available. (Per MM approval, dosing regimen may be modified per physician's decision).
Drug: Vedolizumab
Vedolizumab IV infusion
Other Names:
  • MLN0002
  • Entyvio
  • Kynteles

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 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 regiman 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02743806

Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 71 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02743806     History of Changes
Other Study ID Numbers: Vedolizumab-4013  2016-000678-40  U1111-1180-9339 
Study First Received: April 15, 2016
Last Updated: November 21, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Estonia: State Agency of Medicines
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Agency
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
European Union: European Medicines Agency
Australia: National Health and Medical Research Council
Malaysia: Ministry of Health
New Zealand: Health Research Council
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Singapore: Health Sciences Authority
South Africa: National Health Research Ethics Council
South Korea: Ministry of Food and Drug Safety
Taiwan: Ministry of Health and Welfare
Turkey: Ministry of Health
Ukraine: Ministry of Health
Bulgaria: Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents

ClinicalTrials.gov processed this record on December 07, 2016