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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 CROHN'S DISEASE WHO RESPONDED TO INDUCTION TREATMENT IN M16-006 OR M15-991
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'.
M16-000
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
203526
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 19, 2017
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 -
NCT03105102
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# 169763
Edmonton, Alberta, T5R 1W2
Covenant Health /ID# 161632
Edmonton, Alberta, T6K 4B2
University of Alberta Hospital /ID# 157099
Edmonton, Alberta, T6G 2B7
University of Calgary /ID# 157155
Calgary, Alberta, T2N 4Z6
British Columbia
Fraser Clinical Trials Inc /ID# 159055
New Westminster, British Columbia, V3L 3W4
Giri Gi Research Institute - Vancouver /ID# 157096
Vancouver, British Columbia, V5Z 2K5
Percuro Clinical Research, Ltd /ID# 161631
Victoria, British Columbia, V8V 3M9
Nova Scotia
IWK Health Center /ID# 165905
Halifax, Nova Scotia, B3K 6R8
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 157088
Halifax, Nova Scotia, B3H 2Y9
Ontario
CISSS de la Monteregie Centre - Hopital Charles Le Moyne /ID# 161630
Greenfield Park, Ontario, J4V 2H1
Duplicate_Hamilton Health Sciences -McMaster University Medical Centre /ID# 157184
Hamilton, Ontario, L8S 4K1
London Health Sciences Center- University Hospital /ID# 157161
Medicor Research Inc /ID# 157150
Greater Sudbury, Ontario, P3A 1W8
Mount Sinai Hospital /ID# 169764
Toronto, Ontario, M5G 1X5
Scott Shulman Medicine Professional Corporation /ID# 165906
North Bay, Ontario, P1B 2H3
Toronto Digestive Disease Associates /ID# 157158
Vaughan, Ontario, L4L 4Y7
Quebec
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
Montreal, Quebec, H1T 2M4
Hotel Dieu de Levis /ID# 214377
Montreal General Hospital- McGill University Health Center /ID# 157085
Montreal, Quebec, H3G 1A4
