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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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25 April 2022 |
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Main ID: |
NCT03773445 |
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Date of registration:
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25/11/2018 |
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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 Trough Levels in Patients With Ulcerative Colitis
GLMLEVEL |
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Scientific title:
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Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis |
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Date of first enrolment:
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March 1, 2019 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03773445 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Carlos Taxonera, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital San Carlos, Madrid |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age greater than or equal to 18 years.
- Patients with a diagnosis of ulcerative colitis at least 12 months prior to the start
of the study.
- Patients previously treated with golimumab for ulcerative colitis prescribed according
to the usual clinical practice of each center and who have received at least 5
maintenance doses according to the guidelines accepted in the technical file.
- Sign of informed consent.
Exclusion Criteria:
- Patients with Crohn's disease or colitis pending classification
- Alterations in the coagulation that contraindicate the taking of biopsies
- Patients with moderate-severe heart failure (grades III / IV NYHA)
- Patients with tuberculosis or other serious infections such as septicemia, abscesses
and opportunistic infections
- Psychiatric illness that discourages participation in the study
- Patients with a history of hypersensitivity to golimumab, to other murine proteins or
to any of the excipients included in the golimumab data sheet
- Withdrawal of the informed consent by the patient
- Any other condition that in the opinion of the investigator discourages the
participation of the subject in the study.
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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Diagnostic Test: Golimumab trough levels
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Diagnostic Test: Histology
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Diagnostic Test: Colonoscopy
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Diagnostic Test: Antibodies to golimumab
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Primary Outcome(s)
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Correlation between Golimumab trough levels and Endoscopic remission
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Correlation between Golimumab trough levels and Histological remission
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Correlation between Golimumab trough levels and Endoscopic healing
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Secondary Outcome(s)
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Correlation between Golimumab trough levels and Clinical response
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Correlation between Golimumab trough levels and Clinical remission
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Histological remission
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Receiver operating characteristic curve analysis
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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C-reactive protein and fecal calprotectin.
[Time Frame: Cross-Sectional: 15 days before or after the extraction of levels]
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Secondary ID(s)
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CTS-GOL-2018-01
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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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