ReCOUP is a multicenter clinical study designed to evaluate the efficacy of upadacitinib (Rinvoq®) in patients with ulcerative colitis whose disease has become active again despite maintenance treatment with upadacitinib 30 mg.
This study involves adult patients aged 18 to 64 years with active ulcerative colitis, who are being treated with upadacitinib and are not participating in another interventional clinical trial.
Participation in this study will depend on the patients' response to treatment during the 52-week maintenance period.
Several follow-up visits will be scheduled throughout the study according to a timetable defined by the protocol, and additional visits may be arranged if necessary depending on patients' health status.
Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
Individuals at least 18 years old and less than 65 years.
Serum alanine transaminase (ALT) < 2 × ULN;
Serum aspartate aminotransferase (AST) < 2 x ULN;
Subject with current diagnosis of Crohn's Disease or diagnosis of indeterminate colitis.
Current diagnosis of fulminant colitis and/or toxic megacolon.
History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
Single group
Upadacitinib
DrugUpadacitinib is a selective JAK1 inhibitor. In this study, patients receive higher dose of upadacitinib as re-induction strategy. in the first timepoint, patients are managed according to disease response : patients without clinical response continue on higher updacatinib dose , patients with clinical response undergo endoscopy : patients with a positive endoscopy continue higher upadacitinib dose and patients with a negative endoscopy transition to the maintenance dose.
To determine the rate of re-capture of clinical response in subjects with moderate to severe active ulcerative colitis who had a loss of response to upadacitinib 30 mg QD maintenance dose prior to the study entry.
To determine the proportion of subjects achieving clinical response
To determine the proportion of subjects achieving clinical response
To determine the rate of clinical remission
To determine the proportion of subjects achieving clinical remission
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This trial is not recruiting at the moment. You can still explore other options:
