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

Ulcerative Colitis Clinical Trial

— GOLILOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182166
• Other study ID #: 1608162
• Secondary ID: 2016-004245-85
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2017
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 15, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHU Lyon Sud	Lyon
France	CHU Montpellier - St Eloi	Montpellier
France	CHU Nice	Nice
France	Chu Saint Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 8 weeks
Secondary	Number of patient with antibodies to golimumab	Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)	day 1
Secondary	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.	From baseline to 8 weeks
Secondary	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	up to 8 weeks