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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 March 2022 |
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Main ID: |
NCT03182166 |
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Date of registration:
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29/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
GOLILOR |
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Scientific 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 |
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Date of first enrolment:
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November 21, 2017 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03182166 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Xavier ROBLIN, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de SAINT-ETIENNE |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Golimumab (Optimization)
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Biological: Blood samples
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Diagnostic Test: Rectosigmoidoscopy
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Primary Outcome(s)
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correlation between concentration of golimumab and clinical response according to treatment
[Time Frame: From baseline to 8 weeks]
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Secondary Outcome(s)
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correlation between concentration of antibodies to golimumab and clinical response according to treatment
[Time Frame: From baseline to 8 weeks]
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Number of patient with antibodies to golimumab
[Time Frame: day 1]
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Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
[Time Frame: up to 8 weeks]
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Secondary ID(s)
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1608162
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2016-004245-85
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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