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Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05219656
Collaborator
(none)
182
Enrollment
156
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
182 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. Adverse events [From january 2009 to december 2018]

    Reported treatment related adverse events.

  4. Surgical complications [From January 2009 to December 2018]

    Reported surgical complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

  • Age 16 or over

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

  • Principal Investigator: Heli Eronen, Kanta-Häme Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heli T Eronen, MD, Kanta-Häme Central Hospital
ClinicalTrials.gov Identifier:
NCT05219656
Other Study ID Numbers:
  • R19617
First Posted:
Feb 2, 2022
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heli T Eronen, MD, Kanta-Häme Central Hospital
Cyclosporine A
Rescue therapy
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Cyclosporine
Cyclosporins

Study Results

No Results Posted as of Feb 2, 2022