Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Ulcerative Colitis Acute Clinical Trial

— Cyclo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219656
• Other study ID #: R19617
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 1, 2022
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Acute

Intervention

Drug:
• Cyclosporine A
Rescue therapy in acute severe ulcerative colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Outcome

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