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

NCT07073079 | Recruiting

• 1 other identifier: P25-397
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Upadacitinib; Risankizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Corticosteroids (CS) Free Remission

  CS free remission is defined as clinical remission with Harvey Bradshaw Index (HBI) \<4 and absence of corticosteroid use since at least three months prior to month 12.

  Month 12

Study Arms (2)

Upadacitinib

Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.

Risankizumab

Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Crohn's Disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (25)

Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706

Castellana Grotte, Bari, 70013, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216

Monserrato, Cagliari, 09042, Italy

RECRUITING

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Ospedale San Martino /ID# 274529

Genoa, Genova, 16132, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas /ID# 274489

Rozzano, Lombardy, 20089, Italy

RECRUITING

IRCCS Ospedale San Raffaele /ID# 274458

Milan, Milano, 20132, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682

Monza, Monza E Brianza, 20052, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570

Naples, Napoli, 80131, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788

Naples, Napoli, 80138, Italy

RECRUITING

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461

Turin, Piedmont, 10126, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654

Rome, Roma, 00133, Italy

RECRUITING

Ospedale Sandro Pertini /ID# 275023

Rome, Roma, 00157, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530

Rome, Roma, 00168, Italy

RECRUITING

A.O. Ordine Mauriziano di Torino /ID# 274459

Turin, Torino, 10128, Italy

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462

Negrar, Verona, 37024, Italy

RECRUITING

A.O.U. Consorziale Policlinico di Bari /ID# 274662

Bari, 70124, Italy

RECRUITING

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161

Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliera G. Brotzu /ID# 275125

Cagliari, 09047, Italy

RECRUITING

AOU Policlinico G. Rodolico - San Marco /ID# 274909

Catania, 95123, Italy

RECRUITING

Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571

Catanzaro, 88100, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274618

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964

Palermo, 90146, Italy

RECRUITING

Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460

Pescara, 65124, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488

Roma, 00128, Italy

RECRUITING

Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966

Roma, 00186, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Caterina Golotta

CONTACT

+39 06 548891; caterina.golotta@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 18, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

IT (25)