Trial Profile
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 29 Dec 2023
Price :
$35
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At a glance
- Drugs Upadacitinib (Primary)
- Indications Crohn's disease
- Focus Therapeutic Use
- Acronyms Celest
- Sponsors AbbVie
- 23 Mar 2021 This amendment was made to include patients with inadequate response/intolerance to azathioprine, mercaptopurine, or methotrexate.
- 23 Mar 2021 This amendment stopped the re-randomization into the 24-mg QD arm in the maintenance period and initiated a 6-mg BID arm. Patients who were already assigned to 24 mg QD continued to receive this dosage to the end of the study. All subsequent patients entering the maintenance period were re-randomized 1:1:1 to receive upadacitinib 3 mg, 6 mg, or 12 mg BID.
- 23 Mar 2021 Results of an analysis assessing the health-related quality of life and work productivity improvement published in the Advances in Therapy