Ulcerative ColitisbiologicalNCT05530122
Prognosis in UC After First Biological
An observational study of Ulcerative Colitis, run by Tampere University Hospital.
Trial summary
To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- infliximab, adalimumab, golimumab, vedolizumab, ustekinumab
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to 26 Aug 2022
- How long will I take part?
- 3 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
- Child, Adult, Older adult
Study population: All patients treated in Tampere University Hospital for UC between January 2009 and January 2020 were identified from the digital patient records. Patients at the age of 16 years or over with biological treatment initiated for treatment of moderate to severe UC were included.
Who may be able to join
- Patients treated for ulcerative colitis for the first trial of biological
Who cannot join
- Age under 16 years
About this study
Official title: The Long-term Outcome of Patients With Ulcerative Colitis Treated With First Trial of Biological.
To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.
Read the detailed description
UC patients treated with at least one biological in Tampere University Hospital between January 2009 and January 2020 were identified and reviewed from patient records.
- Conditions
- Ulcerative Colitis
- Being tested
- infliximab, adalimumab, golimumab, vedolizumab, ustekinumab
- Keywords
- infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximab, adalimumab, golimumab, vedolizumab, ustekinumabBiological
Also called small molecules
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Need for colectomy or enhancement of treatment within follow-up
Measured: within 5 years
Side-effects
treatment related side-effects reported
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startJan 2009
- Primary completionJan 2020
- Study completion26 Aug 2022
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
- 192 participants (actual)
- Target duration
- 3 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
- Investigators
- Pekka Collin, PhD, Study director, Tampere University HospitalHeli Eronen, Principal investigator, Central Hospital of Kanta-Häme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530122
- Sponsor's protocol ID
- R20543
- Acronym
- biological
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 7 Sep 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Outcome of Patients With Ulcerative Colitis Treated With First Trial of Biological.
- ClinicalTrials.gov ID
- NCT05530122
- Acronym / sponsor ID
- biological / R20543
- Conditions
- Ulcerative Colitis
- Keywords
- infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 7 Sep 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.
To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.
Detailed description
UC patients treated with at least one biological in Tampere University Hospital between January 2009 and January 2020 were identified and reviewed from patient records.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated in Tampere University Hospital for UC between January 2009 and January 2020 were identified from the digital patient records. Patients at the age of 16 years or over with biological treatment initiated for treatment of moderate to severe UC were included.
Key inclusion criteria (1 listed)
- Patients treated for ulcerative colitis for the first trial of biological
Key exclusion criteria (1 listed)
- Age under 16 years
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 |
|---|---|---|
| infliximab, adalimumab, golimumab, vedolizumab, ustekinumabAlso: small molecules | Biological | – |
Primary outcome
Response to treatment
Time frame: within 5 years
Need for colectomy or enhancement of treatment within follow-up
Side-effects
Time frame: within 5 years
treatment related side-effects reported
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 7 Sep 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.
Pekka Collin, PhD study director
Tampere University Hospital
Heli Eronen principal investigator
Central Hospital of Kanta-Häme
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 1 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 7 Sep 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 to treatment (time frame: within 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 7 Sep 2022; AzTrials last refreshed its copy on 3 Nov 2026.