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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Golimumab (Optimization)
* Diagnostic Test: Rectosigmoidoscopy
* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with golimumab<br>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)<br>* 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.<br>Diagnostic Test: Rectosigmoidoscopy<br>* Rectosigmoidoscopy will be realized for calculated Mayo score<br>Biological: Blood samples<br>* Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with antibodies to golimumab | 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 | 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 | Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis