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

March 11, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens-Picardie
      • Lyon, France
        • CHU Lyon Sud
      • Montpellier, France
        • CHU Montpellier - St Eloi
      • Nice, France
        • CHU Nice
      • Saint Etienne, France, 42055
        • CHU Saint Etienne

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Affiliate or beneficiary of social security
  • Age>18 years
  • Pregnant women or man
  • Presenting primary response under golimumab induction and in loss of response during maintenance therapy
  • Patient with an ulcerative colitis
  • Treated with golimumab
  • Signature of consent

Exclusion Criteria:

  • Trying to become pregnant
  • Mental or emotional disorders
  • Patients with crohn's disease or indeterminate colitis
  • cancer(<5)
  • Patients not in agreement with this study protocol
  • Patients with crohn's disease or indeterminate colitis
  • Patients non primary responder to golimumab

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients treated with golimumab

The optimization procedure is:

  • For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
  • For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks.

They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between concentration of golimumab and clinical response according to treatment
Time Frame: From baseline to 8 weeks

Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA).

Clinical response is measured by the Mayo score.
From baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient with antibodies to golimumab
Time Frame: day 1
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)
day 1
correlation between concentration of antibodies to golimumab and clinical response according to treatment
Time Frame: From baseline to 8 weeks
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) Clinical response is measured by the Mayo score.
From baseline to 8 weeks
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Time Frame: up to 8 weeks
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
up to 8 weeks

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Xavier ROBLIN, MD PhD, CHU de Saint-Etienne

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)

November 21, 2017

Primary Completion (ACTUAL)

June 25, 2021

Study Completion (ACTUAL)

December 15, 2021

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (ACTUAL)

June 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608162
  • 2016-004245-85 (EUDRACT_NUMBER)

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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