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View trial details
Overview
Official protocol title:
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 52-WEEK MAINTENANCE AND AN OPEN-LABEL EXTENSION STUDY OF THE EFFICACY AND SAFETY OF RISANKIZUMAB IN SUBJECTS WITH ULCERATIVE COLITIS WHO RESPONDED TO INDUCTION TREATMENT IN M16-067 OR M16-065
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'.
M16-066
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
215890
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.
May 30, 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 -
NCT03398135
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# 169770
Edmonton, Alberta, T5R 1W2
Covenant Health /ID# 169128
Edmonton, Alberta, T6K 4B2
Duplicate_University of Calgary /ID# 169125
Calgary, Alberta, T2N 4Z6
British Columbia
Fraser Clinical Trials Inc /ID# 169116
New Westminster, British Columbia, V3L 3W4
Percuro Clinical Research, Ltd /ID# 169123
Victoria, British Columbia, V8V 3M9
Ontario
London Health Sciences Center- University Hospital /ID# 169117
Scott Shulman Medicine Professional Corporation /ID# 169127
North Bay, Ontario, P1B 2H3
Toronto Digestive Disease Associates /ID# 169120
Vaughan, Ontario, L4L 4Y7
Quebec
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122
Montreal, Quebec, H1T 2M4
Hotel Dieu de Levis /ID# 214379
Montreal General Hospital- McGill University Health Center /ID# 169118
Montreal, Quebec, H3G 1A4
