NCT05219656

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

10 years

First QC Date

January 21, 2022

Last Update Submit

January 21, 2022

Conditions

Ulcerative Colitis Acute

Keywords

Cyclosporine ARescue therapy

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Cyclosporine ADRUG

Rescue therapy in acute severe ulcerative colitis

Also known as: CyA

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Heli Eronen

    Kanta-Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 2, 2022

Study Start

January 1, 2009

Primary Completion

December 30, 2018

Study Completion

January 1, 2022

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share