Ulcerative ColitisNCT06581042
Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium
An observational study of Ulcerative Colitis and Crohn's Disease, run by AbbVie at 11 sites in Belgium.
Trial summary
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 280 participants
- Where
- 11 sitesBelgium
- Study dates
- 27 Sep 2024to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with ulcerative colitis or Crohn's Disease
Who may be able to join
- Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment.
- Participants initiating commercially available 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 and treatment recommendations
Who cannot join
- Participants previously exposed to upadacitinib in a clinical trial or early access program
- Participants participating in interventional research (not including non-interventional
- Participants with stoma
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Belgium11 sites, 11 recruiting
- Recruiting
Universite Libre de Bruxelles - Hopital Erasme /ID# 268632
Anderlecht, Brussels Capital, 1070
- Recruiting
Imelda Ziekenhuis /ID# 268631
Bonheiden, Antwerpen, 2820
- Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 283334
Genk, Limburg, 3600
- Recruiting
UZ Gent /ID# 268630
Ghent, Oost-Vlaanderen, 9000
- Recruiting
AZ Groeninge /ID# 268638
Kortrijk, West-Vlaanderen, 8500
- Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 268662
Liège, Liege, 4000
- Recruiting
CHU de Liege /ID# 267209
Liège, 4000
- Recruiting
Chu De Charleroi - Hopital Civil Marie Curie /ID# 284063
Lodelinsart, Hainaut, 6042
- Recruiting
AZ-Delta. /ID# 283323
Roeselare, West-Vlaanderen, 8800
- Recruiting
Vitaz /Id# 268637
Sint-Niklaas, Oost-Vlaanderen, 9100
- Recruiting
Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 284064
Tournai, Hainaut, 7500
About this study
Official title: Understanding Local TReatment Patterns and Outcomes With upAdacitinib in IBD Patients in Belgium
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).
Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.
Read more
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. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Ulcerative colitis, Crohn's disease, Upadacitinib, RINVOQ
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis
Clinical remission is defined as: stool frequency (SF) score < = 1 and not greater than baseline and Rectal bleeding (RB) score = 0
Measured: Up to approximately 52 weeks
Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease
Clinical remission is defined as stool frequency (SF) score < =3 and not worse than baseline and Abdominal Pain (AP) score < =1 and not worse than baseline
Measured: Up to approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start27 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581042
- Sponsor's protocol ID
- P24-960
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Local TReatment Patterns and Outcomes With upAdacitinib in IBD Patients in Belgium
- ClinicalTrials.gov ID
- NCT06581042
- Acronym / sponsor ID
- P24-960
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Ulcerative colitis, Crohn's disease, Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).
Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.
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. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | – | –Participants will receive upadacitinib as prescribed by their physician according to local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with ulcerative colitis or Crohn's Disease
Key inclusion criteria (3 listed)
- Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment.
- Participants initiating commercially available 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 and treatment recommendations
Key exclusion criteria (3 listed)
- Participants previously exposed to upadacitinib in a clinical trial or early access program
- Participants participating in interventional research (not including non-interventional
- Participants with stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis
Time frame: Up to approximately 52 weeks
Clinical remission is defined as: stool frequency (SF) score < = 1 and not greater than baseline and Rectal bleeding (RB) score = 0
Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease
Time frame: Up to approximately 52 weeks
Clinical remission is defined as stool frequency (SF) score < =3 and not worse than baseline and Abdominal Pain (AP) score < =1 and not worse than baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by AbbVie at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liesbeth Ghys (844-663-3742, liesbeth.ghys@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis (time frame: Up to approximately 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.