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RecruitingNCT06581042Updated Sep 23, 2026

Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium

An observational study in Ulcerative Colitis and Crohn's Disease, sponsored by AbbVie. Recruiting at 11 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by AbbVie · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Colitis, Ulcerative by AbbVie — 6 open to participants now, 13 under way, 5 of them phase 3. Colitis, Ulcerative · AbbVie.

Planned enrollment
8th of 20
280 · median 200
Started
2024
with 3 others
Observational
20 of 53
4 open now
Primary completion
2029-09
later than 9 of 12 live
Registered
46th of 53
by date

Among the 53 studies in Colitis, Ulcerative by AbbVie, this one is the 8th largest by planned enrollment of the 20 observational ones that give a count, is one of 4 that started in 2024, is one of 20 observational ones, reaches primary completion later than 9 of the 12 other live ones, and was the 46th registered.

Colitis, Ulcerative

1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.

Browse Colitis, Ulcerative studies →

Open to participants now

6 of the 53 studies in Colitis, Ulcerative by AbbVie are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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

03

Conditions studied

  • Ulcerative Colitis
  • Crohn's Disease

Keywords

  • Ulcerative colitis
  • Crohn's disease
  • Upadacitinib
  • RINVOQ
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with ulcerative colitis or Crohn's Disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)

Groups and cohorts

  • Upadacitinib

    Participants will receive upadacitinib as prescribed by their physician according to local label.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to approximately 52 weeks

  2. 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

    Time frame: Up to approximately 52 weeks

07

Study locations

11 of 11 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Sep 2029, 60 months after the start.

Of 83 industry-sponsored observational studies under Colitis, Ulcerative, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 72. This study's planned 60 months is above that.

Counting every sponsor, half of 271 studies reached it within 47 months; a quarter within 29 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2024
First posted
Aug 30, 2024
StartActual
Sep 27, 2024
Primary completionEst.
Sep 2029
CompletionEst.
Sep 2029
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06581042
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Aug 30, 2024
Start date
Sep 27, 2024
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Liesbeth Ghys
Contact
liesbeth.ghys@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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