A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting

Study Identifier
P25-397
CT.gov Identifier
NCT07073079
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes * Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy
    Exclusion Criteria:
    * Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label * Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD

    Protocol Summary

    Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.

    Upadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy.

    Participants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months.

    No additional burden for participants in this trial is expected.

    Study Locations

    Location
    Status
    Location
    Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
    Castellana Grotte, Bari, Italy, 70013
    Status
    Recruiting
    Location
    Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
    Monserrato, Cagliari, Italy, 09042
    Status
    Recruiting
    Location
    Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
    San Giovanni Rotondo, Foggia, Italy, 71013
    Status
    Recruiting
    Location
    Ospedale San Martino /ID# 274529
    Genoa, Genova, Italy, 16132
    Status
    Recruiting
    Location
    IRCCS Istituto Clinico Humanitas /ID# 274489
    Rozzano, Lombardy, Italy, 20089
    Status
    Recruiting
    Location
    IRCCS Ospedale San Raffaele /ID# 274458
    Milan, Milano, Italy, 20132
    Status
    Recruiting
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