Ulcerative Colitis
Conditions
Keywords
golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis
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.
Interventions
BIOLOGICALBlood samples
Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood
DRUGGolimumab (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_TESTRectosigmoidoscopy
Rectosigmoidoscopy will be realized for calculated Mayo score
Sponsors
Merck Sharp & Dohme LLC
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with antibodies to golimumab | day 1 | 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 | 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 |
Countries
France
Outcome results
None listed