Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT03182166
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients treated with golimumab Golimumab (Optimization) 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. Patients treated with golimumab Rectosigmoidoscopy 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. Patients treated with golimumab Blood samples 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.
- Primary Outcome Measures
Name Time Method correlation between concentration of golimumab and clinical response according to treatment From baseline to 8 weeks Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA).
Clinical response is measured by the Mayo score.
- Secondary Outcome Measures
Name Time Method correlation between concentration of antibodies to golimumab and clinical response according to treatment 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.
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever up to 8 weeks Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Number of patient with antibodies to golimumab day 1 Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)
Trial Locations
- Locations (5)
CHU Amiens-Picardie
🇫🇷Amiens, France
CHU Nice
🇫🇷Nice, France
CHU Montpellier - St Eloi
🇫🇷Montpellier, France
CHU Lyon Sud
🇫🇷Lyon, France
Chu Saint Etienne
🇫🇷Saint Etienne, France