An observational study in Ulcerative Colitis Acute, sponsored by Tampere University Hospital. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Tampere University Hospital · Observational
The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 182 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in Tampere University Hospital with Cyclosporine rescue therapy for acute flare of UC.
Exclusion Criteria:
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Rescue therapy in acute severe ulcerative colitis
Also known as: CyA
Response
Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare
Time frame: 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.
Time frame: From january 2009 to december 2018
Adverse events
Reported treatment related adverse events.
Time frame: From january 2009 to december 2018
Surgical complications
Reported surgical complications.
Time frame: From January 2009 to December 2018
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital