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Active (not recruiting) NCT05930275

Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Conditions: Crohn's Disease

Sponsor: AbbVie

trial.available_in: БГ
Overview
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. 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.
Who can participate
Inclusion Criteria: * A diagnosis of moderate-to-severe crohn's disease (CD). * Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study. * Participants prescribed upadacitinib in accordance with the approved local label. * Able to understand and communicate with the investigator and comply with the requirements of the study. * Willing to continue with study documentation after cessation of upadacitinib. * Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app. Exclusion Criteria: * Any contraindication to upadacitinib. * Previously exposure to upadacitinib in a clinical trial. * Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation). * Initiation of upadacitinib prior to enrollment.
Locations 16
Australia (1)
Blacktown Hospital /ID# 258574
Blacktown , New South Wales
Bulgaria (1)
Gastro Med EOOD /ID# 267777
Pazardzhik , Plovdiv
Canada (1)
Foothills Medical Centre /ID# 263475
Calgary , Alberta
China (1)
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873
Beijing , Beijing Municipality
Czech Republic (1)
Fakultní Nemocnice Brno - Jihlavská /ID# 268351
Brno , Brno-mesto
Denmark (1)
Herlev Hospital /ID# 262487
Herlev , Capital Region
Estonia (1)
West Tallinn Central Hospital /ID# 270144
Tallinn , Harju
France (1)
Chu de Nice-Hopital L'Archet Ii /Id# 261060
Nice , Alpes-Maritimes
Greece (1)
Evangelismos Hospital /ID# 268132
Athens , Attica
Hungary (1)
Debreceni Egyetem-Klinikai Kozpont /ID# 258518
Debrecen , Hajdú-Bihar
Ireland (1)
Portiuncula University Hospital /ID# 268856
Ballinasloe , Galway
Italy (1)
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 268732
Monserrato , Cagliari
Japan (1)
Nagoya University Hospital /ID# 266092
Nagoya , Aichi-ken
Netherlands (1)
Radboudumc /ID# 264659
Nijmegen , Gelderland
Romania (1)
Fundeni Clinical Institute /ID# 260354
Bucharest , Bucharest
Spain (1)
Hospital de Sant Joan Despí Moisès Broggi /ID# 263936
Sant Joan Despí , Barcelona
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
19.02.2024
Completion date
01.09.2028
Registry ID
NCT05930275
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.