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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

ClinicalTrials.gov · COMPLETED, 2021

624 participants

Abstract

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Conditions: Crohn's Disease.

Primary outcome: Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12; Percentage of Participants With Endoscopic Response at Week 12; Number of Participants With Adverse Events.

Enrollment: 624 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 624 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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