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

NCT05841537 · tracked via the Priya Life Science Germany tracker

Sponsor

AbbVie

Phase

Observational

Started

2023-06-09

Last updated

2025-05-09

Condition(s) studied

Crohn's Disease

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

—

Healthy volunteers

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. * Participants willing and able to provide authorization to use and disclose personal health information. * Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone). Exclusion Criteria: * Females who are pregnant or breast feeding at baseline. * Participants with any contraindication to risankizumab. * Participants previously exposed to risankizumab. * Participants currently participating in an interventional clinical trial.

Primary outcome measure(s)

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.

Trial sites (154)

Facility	City	Region
Universitaetsklinikum St. Poelten /ID# 258828	Sankt Pölten	Lower Austria
Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824	Vienna	State of Vienna
Medizinische Universitaet Wien /ID# 261472	Vienna	State of Vienna
Medizinische Universitaet Graz /ID# 253559	Graz	Styria
Medizinische Universitaet Innsbruck /ID# 253563	Innsbruck	Tyrol
Klinikum Wels-Grieskirchen GmbH /ID# 253558	Wels	Upper Austria
University of Calgary /ID# 254511	Calgary	Alberta
Gastroenterology and Internal Medicine Research Institution /ID# 253319	Edmonton	Alberta
South Edmonton Gastroenterology Research Clinic /ID# 253160	Edmonton	Alberta
Six08 Gastroenterology /ID# 254513	Lethbridge	Alberta
Dr. Sundeep Singh, Inc /ID# 254250	Kelowna	British Columbia
Fraser Clinical Trials Inc /ID# 254512	New Westminster	British Columbia
Percuro Clinical Research, Ltd /ID# 256339	Victoria	British Columbia
The Moncton Hospital /ID# 252960	Moncton	New Brunswick
Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661	Hamilton	Ontario
Scott Shulman Medicine Professional Corporation /ID# 252961	North Bay	Ontario
Physician's Clinical Research Inc. /ID# 256494	North York	Ontario
Toronto Immune and Digestive Health Institute Inc /ID# 253946	North York	Ontario
Taunton surgical centre /ID# 253812	Oshawa	Ontario
Toronto Digestive Disease Associates /ID# 253813	Vaughan	Ontario
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522	Montreal	Quebec
Royal Victoria Hospital / McGill University Health Centre /ID# 254626	Montreal	Quebec
Diex Recherche Québec /ID# 254016	Québec	Quebec
CIUSSS de l'Estrie - CHUS /ID# 254591	Sherbrooke	Quebec
Hôpital l'Archet /ID# 253097	Nice	Alpes-Maritimes
APHM - Hopital Nord /ID# 253364	Marseille	Bouches-du-Rhone
CHU de Besancon - Jean Minjoz /ID# 253098	Besançon	Doubs
Hopital de la Cavale Blanche /ID# 253100	Brest	Finistere
Centre Hospitalier de Quimper /ID# 254052	Quimper	Finistere
CHU NIMES - Hopital Caremeau /ID# 254060	Nîmes	Gard
Centre Hospitalier Universitaire de Bordeaux /ID# 253095	Pessac	Gironde
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088	Colmar	Grand Est
CHU Toulouse - Hopital Rangueil /ID# 253094	Toulouse	Haute-Garonne
CHU Montpellier - Hopital Saint Eloi /ID# 253096	Montpellier	Herault
CHU Reims - Hôpital Robert Debre /ID# 253366	Reims	Marne
Centre Hospitalier de Dunkerque /ID# 253837	Dunkirk	Nord
CHRU Lille - Hopital Claude Huriez /ID# 253099	Lille	Nord
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091	Créteil	Paris
AP-HP - Hopital Bicetre /ID# 253093	Le Kremlin-Bicêtre	Paris
CHU de Nantes, Hotel Dieu -HME /ID# 254047	Nantes	Pays de la Loire Region

+ 114 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease Recruiting

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients Active, not recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis Recruiting

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05841537 on ClinicalTrials.gov ↗ ← All trials in Germany