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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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19 February 2015 |
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Main ID: |
NCT02186886 |
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Date of registration:
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01/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab
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Scientific title:
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Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi) |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02186886 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Matthias G Breidert, MD |
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Address:
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Telephone:
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+49845671 |
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Email:
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matthias.breidert@klinik-koesching.de |
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Affiliation:
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Name:
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Matthias G Breidert, 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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Naturpark Kliniken Altmuehltal |
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Name:
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Matthias G Breidert, MD |
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Address:
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Telephone:
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+49845671 |
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Email:
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matthias.breidert@klinik-koesching.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- moderate to severe active ulcerative colitis
- qualified for initiating Golimumab therapy, i.e.inadequate response to conventional
therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance
of medical contraindications to such therapies
- must be able and willing to provide written informed consent
- must have a negative tuberculosis screening or if inactive (latent) tuberculosis
diagnosed anti-tuberculosis therapy to be started before initiation of Golimumab
therapy in accordance with local recommendations
Exclusion Criteria:
- cancer
- type one diabetes
- current infection and/or inflammation other than related to ulcerative colitis
- autoimmune diseases
- any contraindications stated by Golimumab product label
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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
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Primary Outcome(s)
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Clinical response
[Time Frame: Week 14]
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Secondary Outcome(s)
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Calprotectin stool levels
[Time Frame: Week 14]
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Calprotectin stool levels
[Time Frame: Week 6]
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Secondary ID(s)
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50831-PIMS-Golimumab-UC
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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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