NCT05896943

Brief Summary

The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

May 8, 2023

Last Update Submit

March 10, 2025

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • the rate of clinical remission

    Total Mayo score of 2 or lower and no subscore higher than 1

    6 months

Secondary Outcomes (3)

  • Endoscopic response rate

    6 months

  • Clinical response rate

    6 months

  • Endoscopic remission rate

    6 months

Study Arms (1)

Ulcerative colitis patients treated with ustekinumab

Patients with Ulcerative Colitis treated with ustekinumab

Drug: Ustekinumab

Interventions

UstekinumabDRUG

Patients with ulcerative colitis treated with ustekinumab

Ulcerative colitis patients treated with ustekinumab

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Ulcerative Colitis treated with Ustekinumab

You may qualify if:

  • Active UC in accordance with applicable diagnostic criteria \[25\] •
  • Aged 18 or above

You may not qualify if:

  • Prior surgical history for UC
  • Toxic megacolon
  • Infectious complications (Cl. Difficile, CMV infection)
  • Patients who received any approved biologic agent (e.g. Infliximab, adalimumab, vedolizumab, golimumab) within the previous 8 weeks or any investigational biologic or other agent in the last 35 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterologist, Chief Department of Gastroenterology, Evangelismos General Hospital of Athens, Athens, Greece

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 9, 2023

Study Start

April 1, 2022

Primary Completion

October 31, 2023

Study Completion

September 25, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

GR(1)