RecruitingNot a traditional drug phaseobservationalRules rewrite

A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Partic…

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

Official registry: https://clinicaltrials.gov/study/NCT07073079 · AbbVie · enrollment listed as 250

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 250 people at 25 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)

Primary outcome (registry wording): Percentage of Participants who Achieve Corticosteroids (CS) Free Remission

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Caterina Golotta

+39 06 548891

caterina.golotta@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

25 listed

Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706 — Castellana Grotte, Bari, Italy (recruiting)
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216 — Monserrato, Cagliari, Italy (recruiting)
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669 — San Giovanni Rotondo, Foggia, Italy (recruiting)
IRCCS Istituto Clinico Humanitas /ID# 274489 — Rozzano, Lombardy, Italy (recruiting)
IRCCS Ospedale San Raffaele /ID# 274458 — Milan, Milano, Italy (recruiting)
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682 — Monza, Monza E Brianza, Italy (recruiting)
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 — Naples, Napoli, Italy (recruiting)
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 — Naples, Napoli, Italy (recruiting)
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461 — Turin, Piedmont, Italy (recruiting)
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654 — Rome, Roma, Italy (recruiting)
Ospedale Sandro Pertini /ID# 275023 — Rome, Roma, Italy (recruiting)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530 — Rome, Roma, Italy (recruiting)

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FAQ about this NCT record

Is NCT07073079 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07073079?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07073079?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary