NCT07077681

Brief Summary

In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice conditions.

  • Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment
  • Secondary objectives:
  • To describe the factors associated with the maintenance of the biosimilar
  • To evaluate the evolution of patients' quality of life
  • To assess the rate of maintenance of clinical remission at M12
  • To describe the acceptability of the biosimilar treatment by patients
  • To evaluate patient satisfaction
  • To evaluate treatment tolerance
  • To describe the reasons for treatment discontinuation that occurred during follow-up
  • To describe the profile of patients who discontinued treatment upon their request.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

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 Progress38%
Jun 2025Dec 2027

Study Start

First participant enrolled

June 2, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 30, 2025

Last Update Submit

July 11, 2025

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

  • maintenance of treatment

    The maintenance of treatment is defined by the continuation of treatment with Uzpruvo®, the biosimilar of ustekinumab, during the twelve months of the study.

    Month 12

Secondary Outcomes (24)

  • Quality of life - SF-36

    Inclusion

  • Quality of life - SF-36

    Month 3

  • Quality of life - SF-36

    Month 6

  • Quality of life - SF-36

    Month 12

  • Quality of life - EQ-5D-5L

    Inclusion

  • +19 more secondary outcomes

Eligibility Criteria

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

Patient with Crohn disease treated by ustekinumab

You may qualify if:

  • Patient aged 18 years or older
  • Patient who has agreed to participate in the study and does not oppose the use of their health data
  • Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections
  • Patients presenting at least one of the following objective criteria: o PCR \< 5 mg/l o Calprotectin \< 250 μg/g o Harvey-Bradshaw index \< 5
  • Patient having internet access enabling them to complete online questionnaires

You may not qualify if:

  • Patient treated with ustekinumab with intervals between injections less than 8 weeks
  • Patients treated with ustekinumab in a pre-filled pen
  • Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...)
  • Patient under legal protection, under guardianship or under curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cabinet Medical

Amiens, 80090, France

RECRUITING

Chu de La Côte Basque

Bayonne, 64109, France

RECRUITING

Chu Besançon - Hopital Jean Minjoz

Besançon, 25000, France

NOT YET RECRUITING

Chu La Cavale Blanche

Brest, France

RECRUITING

Chu Montpellier - Hopital Saint Eloi

Montpellier, 34295, France

RECRUITING

Chu Nantes

Nantes, 44093, France

RECRUITING

Clinique Jules Verne

Nantes, France

RECRUITING

Institut Des Mici Groupe Hospitalier

Neuilly-sur-Seine, 92200, France

RECRUITING

Chu Lyon Sud

Pierre-Bénite, France

RECRUITING

CHU Rouen Normandie

Rouen, 76000, France

RECRUITING

Chu Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 22, 2025

Study Start

June 2, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)