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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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16 December 2017 |
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Main ID: |
NCT02060318 |
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Date of registration:
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10/02/2014 |
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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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Regulatory T-cells and Crohn's Disease
CrohnReg |
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Scientific title:
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The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells |
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Date of first enrolment:
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February 11, 2014 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02060318 |
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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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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Ove Andersen, 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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Hvidovre Hospital & University of Copenhagen |
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Key inclusion & exclusion criteria
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Infliximab group
Inclusion Criteria:
- Crohn's Disease
- Starting Infliximab treatment
- Patient at the gastrointestinal department at Hvidovre Hospital or Køge Sygehus
- Can understand and write Danish
- European ancestry
Exclusion Criteria:
- Not able to consent in an ethical manner (e.g. severe mental illness)
- Significant co-morbidity (e.g. cancer, HIV)
- Other immunological disease (e.g. psoriasis)
- Current treatment with biological agents
Healthy controls
Inclusion Criteria:
- No current disease
- No daily drug use
- Can understand and write Danish
- European ancestry
Exclusion Criteria:
- Not able to consent in an ethical manner (e.g. severe mental illness)
- Significant co-morbidity (e.g. cancer, HIV)
- Other immunological disease (e.g. psoriasis)
- Current treatment with biological agents
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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Crohn Disease
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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Change from baseline in number of regulatory T-cells at 6 weeks
[Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
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Change from baseline in number of regulatory T-cells at 22 weeks
[Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
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Secondary Outcome(s)
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Change from baseline in cytokine levels at 6 weeks
[Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
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Change from baseline in Harvey Bradshaw Index at 6 weeks
[Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
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Change from baseline in Harvey Bradshaw Index at 22 weeks
[Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
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Change from baseline in cytokine levels at 22 weeks
[Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
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Change from baseline in CD161 expression at 22 weeks
[Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
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Change from baseline in CD161 expression at 6 weeks
[Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
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Secondary ID(s)
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HVH-2013-028
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H-1-2013-072
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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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