Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

Last updated: October 28, 2024
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rash

Warts

Rosacea

Treatment

Matched cohort

Brodalumab

Clinical Study ID

NCT05132231
BHC-CANDerm-003
  • Ages > 18
  • All Genders

Study Summary

This is a phase IV, 12-month observational, prospective, open-label, multi-center study that will be conducted across approximately 50 sites in Canada for an estimated study duration of 32 months. All eligible adult participants who are enrolling into the SILIQ Patient Support Program (PSP) and initiating brodalumab as per routine care may be offered participation in the study. If the participant agrees, their verbal consent and details will be entered into the study platform by the enrolling physician so that the participant can access the electronic informed consent form. Participants who meet the eligibility criteria and provide electronic informed consent will be enrolled in the study. The study observation period will be 12 months (±15 days). Data will be collected on approximately 500 participants across academic and community centers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged ≥ 18 years old at the time of verbal consent to participate in the study.

  2. Initiating brodalumab as part of routine clinical care through the SILIQ (brodalumab) Patient Support Program (PSP) for the treatment of plaque psoriasis buthas not yet received their first dose. Decision to treat with brodalumab must havebeen reached prior to and independently of recruitment in the study.

  3. Must be able to read, understand, and communicate in English or French.

  4. Willing and able to provide informed consent on an online platform using anIndependent Ethics Committee (IEC) or Institutional Review Board (IRB) approvedelectronic Informed Consent Form (ICF) in English or French.

Exclusion

Exclusion Criteria:

  1. Not willing or able to complete ePROs (electronic Patient Reported Outcomes) on anonline platform (using a computer or mobile device).

  2. Participation in brodalumab phase IV study (NCT04149587).

  3. Participation in an interventional clinical trial concurrently or within the last 30days prior to providing verbal consent to participate in this study.

  4. Patient with Crohn's disease or with clinically significant hypersensitivity tobrodalumab or to any of the excipients or component of the container (contraindications as per the Product Monograph).

  5. Presence of any other serious and/or uncontrolled medical condition that, in theopinion of the investigator, prohibits the patient from participating in the study.

Study Design

Total Participants: 394
Treatment Group(s): 2
Primary Treatment: Matched cohort
Phase:
Study Start date:
October 22, 2021
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • CARE Site 15

    Calgary, Alberta T5J 3S9
    Canada

    Site Not Available

  • CARE Site 26

    Calgary, Alberta T2W 4X9
    Canada

    Site Not Available

  • CARE Site 42

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • CARE Site 18

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • CARE Site 21

    Edmonton, Alberta T6W 0J5
    Canada

    Site Not Available

  • CARE Site 37

    Edmonton, Alberta T6X 0N9
    Canada

    Site Not Available

  • CARE Site 41

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • CARE Site 28

    Sherwood Park, Alberta T8H 0P1
    Canada

    Site Not Available

  • CARE Site 31

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • CARE Site 12

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • CARE Site 36

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • CARE Site 35

    Saint Johns, Newfoundland and Labrador A1E 1V4
    Canada

    Site Not Available

  • CARE Site 11

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • CARE Site 05

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • CARE Site 20

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • CARE Site 14

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • CARE Site 24

    Hamilton, Ontario L9B 1K5
    Canada

    Site Not Available

  • CARE Site 09

    London, Ontario N6H 5L6
    Canada

    Site Not Available

  • CARE Site 22

    London, Ontario N6A 5R9
    Canada

    Site Not Available

  • CARE Site 23

    London, Ontario N6A 2C2
    Canada

    Site Not Available

  • CARE Site 33

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • CARE Site 44

    Mississauga, Ontario L4W 0C2
    Canada

    Site Not Available

  • CARE Site 51

    Niagara Falls, Ontario L2E 6A6
    Canada

    Site Not Available

  • CARE Site 48

    North York, Ontario M3B 0A7
    Canada

    Site Not Available

  • CARE Site 27

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • CARE Site 13

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • CARE Site 06

    Sudbury, Ontario P3C 1XB
    Canada

    Site Not Available

  • CARE Site 16

    Toronto, Ontario M5A 3R6
    Canada

    Site Not Available

  • CARE Site 49

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • CARE Site 32

    Whitby, Ontario L1N 8M7
    Canada

    Site Not Available

  • CARE Site 38

    Drummondville, Quebec J2B 5L4
    Canada

    Site Not Available

  • CARE Site 07

    Laval, Quebec H7N 6L2
    Canada

    Site Not Available

  • CARE Site 50

    Laval, Quebec H7P K7
    Canada

    Site Not Available

  • CARE Site 04

    Montréal, Quebec H2E 1V4
    Canada

    Site Not Available

  • CARE Site 52

    Saint-Charles-Borromée, Quebec J6E 4P6
    Canada

    Site Not Available

  • CARE Site 39

    Saint-Jérôme, Quebec J7Z 7E2
    Canada

    Site Not Available

  • CARE Site 47

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • CARE Site 40

    Westmount, Quebec H3Z 2S6
    Canada

    Site Not Available

  • CARE Site 03

    Saskatoon, Saskatchewan S7T 0G3
    Canada

    Site Not Available

  • CARE Site 17

    Quebec, G3K 2P8
    Canada

    Site Not Available

  • CARE Site 30

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • CARE Site 46

    Quebec, G1V T3
    Canada

    Site Not Available

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