Language and content disclaimer
The content and search results on this site are collected from or provided by third parties. As such some of the information may only be available in the language originally submitted by the sponsor of the trial. Learn more about the information on the search portal.
Linking to Non-Government of Canada Websites
Links to websites not under the control of the Government of Canada, including those to our social media accounts, and to clinical trial records in international registries are provided solely for the convenience of our website visitors. We are not responsible for the accuracy, currency or reliability of the content of such websites. The Government of Canada does not offer any guarantee in that regard and is not responsible for the information found through these links, nor does it endorse the sites and their content.
Visitors should also be aware that information offered by non-Government of Canada sites to which this website links is not subject to the Privacy Act or the Official Languages Act and may not be accessible to persons with disabilities. The information offered may be available only in the language(s) used by the sites in question. With respect to privacy, visitors should research the privacy policies of these non-government websites before providing personal information.
View trial details
Overview
Official protocol title:
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MAINTENANCE AND LONG-TERM EXTENSION STUDY OF THE EFFICACY AND SAFETY OF UPADACITINIB (ABT-494) IN SUBJECTS WITH CROHN'S DISEASE WHO COMPLETED THE STUDIES M14-431 OR M14-433
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
UPADACITINIB (ABT-494)
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
M14-430
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
217374
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Active, not recruiting
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
July 20, 2018
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT03345823
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
No
Locations
Alberta
Allen Whey Khye Lim Professional Corporation /ID# 168047
Edmonton, Alberta, T5R 1W2
Covenant Health /ID# 166996
Edmonton, Alberta, T6K 4B2
University of Alberta Hospital /ID# 166987
Edmonton, Alberta, T6G 2B7
University of Calgary /ID# 166990
Calgary, Alberta, T2N 4Z6
British Columbia
Fraser Clinical Trials Inc /ID# 166984
New Westminster, British Columbia, V3L 3W4
Giri Gi Research Institute - Vancouver /ID# 166994
Vancouver, British Columbia, V5Z 2K5
Nova Scotia
QEII - Health Sciences Centre /ID# 169308
Halifax, Nova Scotia, B3H 2Y9
Ontario
London Health Sciences Center- University Hospital /ID# 221039
Medicor Research Inc /ID# 166997
Greater Sudbury, Ontario, P3A 1W8
Ottawa Hospital Research Institute /ID# 212412
Scott Shulman Medicine Professional Corporation /ID# 169065
North Bay, Ontario, P1B 2H3
Taunton surgical centre /ID# 168045
Toronto Digestive Disease Associates /ID# 166988
Vaughan, Ontario, L4L 4Y7
Quebec
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170122
Montreal, Quebec, H2X 0A9
CIUSSS de l'Estrie - CHUS /ID# 170936
Sherbrooke, Quebec, J1G 2E8
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 170011
Montreal, Quebec, H4A 3J1
Hotel Dieu de Levis /ID# 166985
