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APPRISE: An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05841537
Collaborator
(none)
1,000
Enrollment
49
Locations
52
Anticipated Duration (Months)
20.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)
    Anticipated Study Start Date :
    Apr 30, 2023
    Anticipated Primary Completion Date :
    Aug 31, 2027
    Anticipated Study Completion Date :
    Aug 31, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Risankizumab

    Participants will receive risankizumab as prescribed by their physician according to local label.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3 [At Month 12]

      Clinical Remission is defined as HBI <= 4. Clinical Response is defined as HBI reduction >= 3 points. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient-reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices.

    • Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care.

    • Participants prescribed risankizumab in accordance with the approved local label.

    • Participants able to understand and communicate with the investigator and comply with the requirements of the study.

    Exclusion Criteria:

    • Participants with any contraindication to risankizumab.

    • Participants previously exposed to risankizumab in a clinical trial.

    • Participants currently participating in an interventional clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Calgary /ID# 254511 Calgary Alberta Canada T2N 4Z6
    2 Gastroenterology and Internal Medicine Research Institution /ID# 253319 Edmonton Alberta Canada T5R 1W2
    3 South Edmonton Gastroenterology Research Clinic /ID# 253160 Edmonton Alberta Canada T6K 4B2
    4 Six08 Gastroenterology /ID# 254513 Lethbridge Alberta Canada T1J 4G9
    5 Dr. Sundeep Singh, Inc /ID# 254250 Kelowna British Columbia Canada V1Y 6J6
    6 Fraser Clinical Trials Inc /ID# 254512 New Westminster British Columbia Canada V3L 3W4
    7 The Moncton Hospital /ID# 252960 Moncton New Brunswick Canada E1C 6Z8
    8 Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661 Hamilton Ontario Canada L8S 4K1
    9 Scott Shulman Medicine Professional Corporation /ID# 252961 North Bay Ontario Canada P1B 2H3
    10 Toronto Immune and Digestive Health Institute Inc /ID# 253946 North York Ontario Canada M6A 3B4
    11 Taunton Surgical Centre /ID# 253812 Oshawa Ontario Canada L1H 7K4
    12 Toronto Digestive Disease Asso /ID# 253813 Vaughan Ontario Canada L4L 4Y7
    13 CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522 Montreal Quebec Canada H1T 2M4
    14 Royal Victoria Hospital / McGill University Health Centre /ID# 254626 Montreal Quebec Canada H4A 3J1
    15 Diex Recherche Québec Inc. /ID# 254016 Québec Quebec Canada G1V 4T3
    16 CIUSSS de l'Estrie - CHUS /ID# 254591 Sherbrooke Quebec Canada J1G 2E8
    17 HCL - Hopital Lyon Sud /ID# 253104 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    18 APHM - Hopital Nord /ID# 253364 Marseille Bouches-du-Rhone France 13015
    19 CHU de Besancon - Jean Minjoz /ID# 253098 Besancon Doubs France 25030
    20 Centre Hospitalier de Quimper /ID# 254052 Quimper CEDEX Finistere France 29107
    21 CHU NIMES - Hopital Caremeau /ID# 254060 Nimes CEDEX 9 Gard France 30029
    22 CHU Bordeaux - Hopital Haut Leveque /ID# 253095 Pessac Gironde France 33604
    23 CHRU Lille - Hopital Claude Huriez /ID# 253099 Lille Hauts-de-France France 59037
    24 CHU Montpellier - Hôpital Saint Eloi /ID# 253096 Montpellier Cedex 5 Herault France 34295
    25 Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 253358 Neuilly Sur Seine Ile-de-France France 92200
    26 CHU de SAINT ETIENNE - Hopital Nord /ID# 253102 St. Priest En Jarez Loire France 42270
    27 CHU Reims - Hôpital Robert Debre /ID# 253366 Reims CEDEX Marne France 51092
    28 Centre Hospitalier de Dunkerque /ID# 253837 Dunkirk CEDEX 1 Nord France 59385
    29 CHU de Nantes, Hotel Dieu -HME /ID# 254047 Nantes Pays-de-la-Loire France 44000
    30 CHU Amiens-Picardie Site Sud /ID# 253089 Amiens CEDEX 1 Somme France 80054
    31 CHU Poitiers - La miletrie /ID# 254443 Poitiers Vienne France 86000
    32 Hopital de la Cavale Blanche /ID# 253100 Brest France 29200
    33 CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368 Caen France 14033
    34 CHRU Tours - Hopital Trousseau /ID# 253369 Chambray Les Tours France 37170
    35 Clinique de Bercy /Id# 253139 Charenton le Pont France 94220
    36 Hopitaux Civils de Colmar /ID# 253088 Colmar France 68000
    37 Hopital Henri Mondor /ID# 253091 Creteil France 94000
    38 CH Annecy Genevois - Site Annecy /ID# 253103 Epagny Metz Tessy France 74370
    39 CH Haguenau /ID# 253109 Haguenau France 67500
    40 CHU Grenoble - Hopital Michallon /ID# 253101 La Tronche France 38700
    41 AP-HP - Hôpital Bicêtre /ID# 253093 Le Kremlin Bicetre France 94270
    42 Clinique Jules Verne /ID# 253939 Nantes France 44300
    43 Hôpital l'Archet /ID# 253097 Nice Cedex 3 France 06202
    44 AP-HP - Hopital Saint-Antoine /ID# 254044 Paris France 75012
    45 CHU de Rouen /ID# 253107 Rouen CEDEX France 76031
    46 Centre Hospitalier Tarbes-Lourdes /ID# 253943 Tarbes CEDEX 9 France 65013
    47 CH Toulon - Hopital Sainte Musse /ID# 255442 Toulon France 83100
    48 CHU Toulouse - Hopital Rangueil /ID# 253094 Toulouse France 31400
    49 Hôpital Schuman /ID# 254781 Vantoux France 57070

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05841537
    Other Study ID Numbers:
    • P22-920
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Crohn's Disease
    CD
    Risankizumab
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of May 3, 2023