Prognosis in UC After First Biological (biological)

September 2, 2022 updated by: Heli T Eronen, Tampere University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients treated for ulcerative colitis for the first trial of biological

Exclusion Criteria:

  • Age under 16 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment
Time Frame: within 5 years
Need for colectomy or enhancement of treatment within follow-up
within 5 years
Side-effects
Time Frame: within 5 years
treatment related side-effects reported
within 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Study Director: Pekka Collin, PhD, Tampere University Hospital
  • Principal Investigator: Heli Eronen, Central Hospital of Kanta-Häme

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R20543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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