Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Completed

• Conditions: Ulcerative Colitis Acute

• Registration Number: NCT05219656
• Lead Sponsor: Tampere University Hospital

Brief Summary

The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

Detailed Description

All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2018-12-30
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
• Age 16 or over

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response	From january 2009 to december 2018	Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare
Surgical complications	From January 2009 to December 2018	Reported surgical complications.
Remission	From january 2009 to december 2018	Remission was defined as no need for further corticosteroids, re-hospitalization, enhancement of treatment with biologicals or small molecules or colectomy within follow-up.
Adverse events	From january 2009 to december 2018	Reported treatment related adverse events.