An observational study in Ulcerative Colitis, sponsored by AbbVie. Active, not recruiting at 153 sites in 17 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by AbbVie · Observational
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.
Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 783 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with moderately to severely active Ulcerative colitis (UC)
Exclusion Criteria:
Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.
Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
The first clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1. Median time to achieve the first CR per partial adapted mayo score will be reported
Time frame: Up to approximately week 156
Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16)
Clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1.
Time frame: Week 52
Showing the first 100 of 153 sites across 17 countries.
Plan to share: Undecided
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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AbbVie