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Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

NCT03182166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-03-14

No results posted yet for this study

Summary

It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.

Conditions

Interventions

DRUG

Golimumab (Optimization)

Increase dose of golimumab. * For patients treated at 50 mg will be performed, dose will be intensified at 100 mg every four weeks. * For patients treated at 100 mg will be performed, dose will be intensified at 100 mg every two weeks while four weeks.

DIAGNOSTIC_TEST

Rectosigmoidoscopy

Rectosigmoidoscopy will be realized for calculated Mayo score

BIOLOGICAL

Blood samples

Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood

Sponsors & Collaborators

Principal Investigators

  • Xavier ROBLIN, MD PhD · CHU de SAINT-ETIENNE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2021-06-25
Completion
2021-12-15

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182166 on ClinicalTrials.gov