Ulcerative ColitisNCT04564638
Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids
An observational study of Ulcerative Colitis, run by Tampere University Hospital.
Trial summary
All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Corticosteroid
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 1 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: IBD patients treated in hospital ward with first intravenous corticosteroid
Who may be able to join
- Acute severe ulcerative colitis treated first time with iv corticosteroids
- Follow-up for at least six months after hospitalization or until colectomy.
- Exlusion:
- -Under 16 year of age
Who cannot join
None listed.
About this study
All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.
Read the detailed description
Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR >30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.
- Conditions
- Ulcerative Colitis
- Being tested
- Corticosteroid
- Keywords
- corticosteroids, cyclosporine, colectomy, clinical outcome
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called cyclosporine
What is being measured
The primary outcome is the main question the study is designed to answer.
Colectomy
We reviewed patient records for data on need for surgery within follow-up. We identified patients who had emergency colectomy and patients who needed surgery within 1 year of index flare or within follow-up.
Measured: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.
Responce to Corticosteroid
Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.
Measured: Admission on index flare
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Mar 2015
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- 217 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, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564638
- Sponsor's protocol ID
- R15518S
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids
- ClinicalTrials.gov ID
- NCT04564638
- Acronym / sponsor ID
- R15518S
- Conditions
- Ulcerative Colitis
- Keywords
- corticosteroids, cyclosporine, colectomy, clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 25 Sep 2020 (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.
All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.
Detailed description
Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR >30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IBD patients treated in hospital ward with first intravenous corticosteroid
Key inclusion criteria (4 listed)
- Acute severe ulcerative colitis treated first time with iv corticosteroids
- Follow-up for at least six months after hospitalization or until colectomy.
- -Under 16 year of age
Key exclusion criteria (0 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 |
|---|---|---|
| CorticosteroidAlso: cyclosporine | Drug | – |
Primary outcome
Colectomy
Time frame: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.
We reviewed patient records for data on need for surgery within follow-up. We identified patients who had emergency colectomy and patients who needed surgery within 1 year of index flare or within follow-up.
Responce to Corticosteroid
Time frame: Admission on index flare
Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.
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 25 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, 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 4 inclusion and 0 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 25 Sep 2020. 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?
Colectomy (time frame: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.). The study lists 2 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 25 Sep 2020.