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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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12 December 2020 |
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Main ID: |
NCT03669029 |
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Date of registration:
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04/07/2018 |
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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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Optimization of Golimumab Treatment in Ulcerative Colitis
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Scientific title:
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Optimization of Golimumab Treatment in Ulcerative Colitis |
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Date of first enrolment:
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October 1, 2018 |
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Target sample size:
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50 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03669029 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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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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Joaquín Hinojosa del Val, MD |
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Address:
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Telephone:
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+34 651184296 |
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Email:
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jhinojosad@gmail.com |
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Affiliation:
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Name:
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Joaquín Hinojosa del Val, MD |
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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 de Manises |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult subjects (18 years or older, both sexes and any race) who will be treated with
Golimumab according to clinical criteria.
Exclusion Criteria:
- Patients with Crohn's disease or colitis pending classification
- Patients with ileoanal pouch
- Patients with perianal fistulas related to the disease
- Patients with a history of hypersensitivity to golimumab, other murine proteins, or to
any of the excipients included in the golimumab datasheet.
- Patients with tuberculosis or other serious infections such as septicemia, abscesses
and opportunistic infections.
- Patients with moderate or severe heart failure (NYHA grade III / IV)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colitis, Ulcerative
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Intervention(s)
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Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
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Drug: Golimumab treatment optimization.
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Primary Outcome(s)
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Correlation between anti-Golimumab antibody levels and clinical response.
[Time Frame: Week 6.]
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Correlation between serum Golimumab levels and clinical response.
[Time Frame: Week 6.]
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Secondary Outcome(s)
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Treatment optimization outcome.
[Time Frame: Week 14]
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Correlation between mucosal healing and serum Golimumab levels.
[Time Frame: Week 54]
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Correlation between mucosal healing and anti-Golimumab antibody levels.
[Time Frame: Week 54]
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Identification of cut-off values of serum golimumab concentration
[Time Frame: Week 6]
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Secondary ID(s)
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JHV-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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