Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis. (Cyclo)

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis Acute
• Intervention / Treatment: Drug: Cyclosporine A

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 Type: Observational
• Enrollment (Actual): 182

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated in Tampere University Hospital with Cyclosporine rescue therapy for acute flare of UC.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Adverse events	Reported treatment related adverse events.	From january 2009 to december 2018
Surgical complications	Reported surgical complications.	From January 2009 to December 2018

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Heli Eronen, Kanta-Häme Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2009
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (ACTUAL): February 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cyclosporine A; Rescue therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: R19617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No