Exploratory study of the efficacy and safety of salazosulfapyridine for immune checkpoint inhibitor related colitis - iRECSA study

Yamada Takeshi0 sites10 target enrollmentNovember 19, 2021

Overview

No summary available.

Registry

who.int

Start Date

November 19, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yamada Takeshi

•1\) Diarrhea or bloody stool lasting more than 1 week during immune checkpoint inhibitor (ICI) administration or within 3 months of discontinuation
•2\) Mayo score 3\-10 points and Mayo endoscopic subscore 1 point or higher
•3\) Age more than 20 years
•4\) Eastern Cooperative Oncology Group performance status 0\-2
•5\) Written informed consent was obtained from patient after providing a detailed explanation of the clinical study prior to registration

•1\) Colonoscopic findings clearly indicate that the cause is another disease
•2\) A history of inflammatory bowel disease
•3\) Concomitant use of prohibited drugs
•4\) Using or planning to use steroids during 1 week before registration or 2 weeks after registration
•5\) Complicated or suspected toxic megacolon or gastrointestinal perforation
•6\) Complications of other poorly controlled irAEs at the time of registration
•7\) Severe liver disease (AST or ALT \>100 IU/L)
•8\) Severe kidney disease (serum creatinine \>2 mg/dl)
•9\) History of hypersensitivity to sulfa drugs or salicylic acid products
•10\) Poorly controlled bronchial asthma (rpeated asthma attacks within a month)