Ulcerative Colitis AcuteCycloNCT05219656
Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.
An observational study of Ulcerative Colitis Acute, run by Tampere University Hospital.
Trial summary
The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis Acute
- What is being tested?
- Cyclosporine A
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Jan 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in Tampere University Hospital with Cyclosporine rescue therapy for acute flare of UC.
Who may be able to join
- Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
- Age 16 or over
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis Acute
- Being tested
- Cyclosporine A
- Keywords
- Cyclosporine A, Rescue therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Also called CyA
Rescue therapy in acute severe ulcerative colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare
Measured: 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.
Measured: From january 2009 to december 2018
Adverse events
Reported treatment related adverse events.
Measured: From january 2009 to december 2018
Surgical complications
Reported surgical complications.
Measured: From January 2009 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Jan 2009
- Primary completion30 Dec 2018
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis AcuteStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 182 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heli T Eronen, Kanta-Häme Central Hospital
- Investigators
- Heli Eronen, Principal investigator, Kanta-Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219656
- Sponsor's protocol ID
- R19617
- Acronym
- Cyclo
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.
- ClinicalTrials.gov ID
- NCT05219656
- Acronym / sponsor ID
- Cyclo / R19617
- Conditions
- Ulcerative Colitis Acute
- Keywords
- Cyclosporine A, Rescue therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.
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
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in Tampere University Hospital with Cyclosporine rescue therapy for acute flare of UC.
Key inclusion criteria (2 listed)
- Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
- Age 16 or over
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine AAlso: CyARescue therapy in acute severe ulcerative colitis | Drug | – |
Primary outcome
Response
Time frame: 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
Remission
Time frame: 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.
Adverse events
Time frame: From january 2009 to december 2018
Reported treatment related adverse events.
Surgical complications
Time frame: From January 2009 to December 2018
Reported surgical complications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heli Eronen principal investigator
Kanta-Häme Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis Acute, run by Tampere University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: From january 2009 to december 2018). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.