Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05219656

Acronym

Cyclo

Enrollment

182

Registered

2022-02-02

Start date

2009-01-01

Completion date

2022-01-01

Last updated

2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis Acute

Keywords

Cyclosporine A, Rescue therapy

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.

Interventions

DRUGCyclosporine A

Rescue therapy in acute severe ulcerative colitis

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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
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.
Surgical complications	From January 2009 to December 2018	Reported surgical complications.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026