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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Golimumab (Optimization)
Rectosigmoidoscopy
Blood samples
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens-Picardie
  • CHU Lyon Sud
  • CHU Montpellier - St Eloi
  • CHU Nice
  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated with golimumab

Arm Description

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.

Outcomes

Primary Outcome Measures

correlation between concentration of golimumab and clinical response according to treatment
Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA). Clinical response is measured by the Mayo score.

Secondary Outcome Measures

Number of patient with antibodies to golimumab
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)
correlation between concentration of antibodies to golimumab and clinical response according to treatment
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) Clinical response is measured by the Mayo score.
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever

Full Information

First Posted
May 29, 2017
Last Updated
March 11, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03182166
Brief Title
Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Acronym
GOLILOR
Official Title
Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with golimumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Golimumab (Optimization)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Rectosigmoidoscopy
Intervention Description
Rectosigmoidoscopy will be realized for calculated Mayo score
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood
Primary Outcome Measure Information:
Title
correlation between concentration of golimumab and clinical response according to treatment
Description
Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA). Clinical response is measured by the Mayo score.
Time Frame
From baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Number of patient with antibodies to golimumab
Description
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)
Time Frame
day 1
Title
correlation between concentration of antibodies to golimumab and clinical response according to treatment
Description
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) Clinical response is measured by the Mayo score.
Time Frame
From baseline to 8 weeks
Title
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Description
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
Country
France
Facility Name
CHU Lyon Sud
City
Lyon
Country
France
Facility Name
CHU Montpellier - St Eloi
City
Montpellier
Country
France
Facility Name
CHU Nice
City
Nice
Country
France
Facility Name
Chu Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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