Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Condition(s) studied

Study summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world.

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. Study visits may be conducted on-site or virtually as per standard of care.

Eligibility

Primary outcome measure(s)

• Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) — Up to Week 12
  Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or \>= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as \>= 30% decrease in average daily very soft or liquid SF and/or \>= 30% decrease in average daily AP score and both not worse than baseline.
• Percentage of Participants Achieving Clinical Remission per Harvey Bradshaw Index (HBI) Among those with Clinical Response-Harvey Bradshaw Index (CR-HBI) at End of Induction Therapy — At Week 52
  Clinical Remission is defined as HBI \<= 4. Clinical Response is defined as HBI reduction \>= 3 points from baseline. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores \< 5 indicate clinical remission, 5 - 7 indicate mild disease activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.

Trial sites (180)

+ 140 more sites — see the full list on the official registry below.

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