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View trial details
Overview
Official protocol title:
A PHASE 3, MULTICENTER, RANDOMIZED, EFFICACY ASSESSOR-BLINDED STUDY OF RISANKIZUMAB COMPARED TO USTEKINUMAB FOR THE TREATMENT OF ADULT SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE WHO HAVE FAILED ANTI-TNF THERAPY
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.
RISANKIZUMAB (ABBV-066)
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'.
M20-259
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
242877
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.
September 17, 2020
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 -
NCT04524611
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# 223755
Edmonton, Alberta, T5R 1W2
Covenant Health /ID# 223753
Edmonton, Alberta, T6K 4B2
Duplicate_University of Calgary /ID# 223750
Calgary, Alberta, T2N 4Z6
British Columbia
Fraser Clinical Trials Inc /ID# 223742
New Westminster, British Columbia, V3L 3W4
Percuro Clinical Research, Ltd /ID# 223747
Victoria, British Columbia, V8V 3M9
Nova Scotia
QEII - Health Sciences Centre /ID# 223748
Halifax, Nova Scotia, B3H 2Y9
Ontario
Axler, Toronto, ON. Canada /ID# 223740
Toronto, Ontario, M9V 0A9
London Health Sciences Centre - University Hospital /ID# 223741
Mount Sinai Hospital /ID# 223752
Toronto, Ontario, M5G 1X5
Scott Shulman Medicine Professional Corporation /ID# 223754
North Bay, Ontario, P1B 2H3
Quebec
CISSS de la Monteregie /ID# 224399
Greenfield Park, Quebec, J4V 2H1
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
Duplicate_Duplicate_CHUS - Hopital Fleurimont /ID# 224819
Sherbrooke, Quebec, J1H 5N4
Montreal General Hospital- McGill University Health Center /ID# 223743
Montreal, Quebec, H3G 1A4
