Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

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

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Key information

Conditions

Ulcerative Colitis Acute

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Cyclosporine A

Drug

Rescue therapy in acute severe ulcerative colitis

Other names: CyA

Primary outcomes

Response

Time frame: 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

Time frame: 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

Time frame: From january 2009 to december 2018

Reported treatment related adverse events.
Surgical complications

Time frame: From January 2009 to December 2018

Reported surgical complications.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Acronym: Cyclo

Important dates

Study start: 2009
Primary completion: 2018
Study completion: 2022
First posted: Feb 2, 2022
Registry last updated: Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed