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. 2022 Apr 7;2022(4):CD007216. doi: 10.1002/14651858.CD007216.pub2

JPRN‐UMIN000007406.

Methods Study design: randomised, parallel group trial
Setting: Jichi Medical University hospital for induction of remission
Study period: 1 April 2012 to NR
Participants Inclusion criteria: adults aged 20–75 years; moderate‐to‐severe active UC; people with comorbidities should be stable and no alterations to their therapeutic regimen are expected; able to understand and sign an informed consent
Exclusion criteria: hypersensitivity or contraindication to tacrolimus; unable to make an informed consent due to any disorder such as dementia
20 participants
Disease activity: NR
Disease duration: NR
Extent of disease: NR
Age: NR
Sex (M/F): NR
Concurrent therapies: NR
Number enrolled: NR
Number randomised: NR
Number reaching end of study: NR
Interventions IG: conventional steroid tapering (5 mg/day every 2 weeks)
CG: rapidly tapering dose of steroids
Outcomes Primary outcome:
Mayo score
Secondary outcome:
Stool frequency, rectal bleeding, Matts Score, C‐reactive protein
Duration: NR
Length of intervention and follow‐up points: NR
Definition of remission or clinical improvement by study authors: NR
Number of participants who achieved remission: NR
Number of participants who achieved clinical improvement: NR
Time to onset of action for tacrolimus from beginning of study: NR
Number of participants who required other rescue medication: NR
Time to other rescue medication from beginning of study: NR
Number of participants who underwent surgery: NR
Time to surgery from beginning of study: NR
Adverse events: NR
Withdrawal due to adverse events: NR
Serious adverse events: NR
Time to adverse events from beginning of study: NR
Notes Contacted author by email on 23 November 2020 for further information; the email was undeliverable.