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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004245-85 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with golimumab | Experimental | The optimization procedure is:
They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab (Optimization) | Drug | Increase dose of golimumab.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier ROBLIN, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | ||||
| CHU Lyon Sud |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2023 | |
| Reset | Jan 11, 2024 | |
| Release | Aug 2, 2024 |
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|
| Rectosigmoidoscopy | Diagnostic Test | Rectosigmoidoscopy will be realized for calculated Mayo score |
|
| Blood samples | Biological | Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood |
|
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 |
| Lyon |
| France |
| CHU Montpellier - St Eloi | Montpellier | France |
| CHU Nice | Nice | France |
| Chu Saint Etienne | Saint-Etienne | 42055 | France |
| Reset | Oct 24, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2023 | Jan 11, 2024 | |||
| Aug 2, 2024 | Oct 24, 2024 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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