Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

NCT ID: NCT05219656

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Ulcerative Colitis Acute

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Cyclosporine A

Rescue therapy in acute severe ulcerative colitis

Intervention Type: DRUG

Other Intervention Names

CyA

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heli T Eronen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heli Eronen

Role: PRINCIPAL_INVESTIGATOR

Kanta-Häme Central Hospital

Other Identifiers

R19617

Identifier Type: -

Identifier Source: org_study_id