NCT05530122

Brief Summary

To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

11 years

First QC Date

August 29, 2022

Last Update Submit

September 2, 2022

Conditions

Ulcerative Colitis

Keywords

infliximabadalimumabgolimumabustekinumabvedolizumabtofacitinib

Outcome Measures

Primary Outcomes (2)

  • Response to treatment

    Need for colectomy or enhancement of treatment within follow-up

    within 5 years

  • Side-effects

    treatment related side-effects reported

    within 5 years

Interventions

infliximab, adalimumab, golimumab, vedolizumab, ustekinumabBIOLOGICAL
Also known as: small molecules

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Age under 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

InfliximabAdalimumabgolimumabvedolizumabUstekinumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Humanized

Study Officials

  • Pekka Collin, PhD

    Tampere University Hospital

    STUDY DIRECTOR

  • Heli Eronen

    Central Hospital of Kanta-Häme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 7, 2022

Study Start

January 1, 2009

Primary Completion

January 1, 2020

Study Completion

August 26, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share