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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02060318
Date of registration: 10/02/2014
Prospective Registration: Yes
Primary sponsor: Hvidovre University Hospital
Public title: Regulatory T-cells and Crohn's Disease CrohnReg
Scientific title: The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells
Date of first enrolment: February 11, 2014
Target sample size: 47
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02060318
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Ove Andersen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Hvidovre Hospital & University of Copenhagen
Key inclusion & exclusion criteria

Infliximab group

Inclusion Criteria:

- Crohn's Disease

- Starting Infliximab treatment

- Patient at the gastrointestinal department at Hvidovre Hospital or K√łge 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
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Change from baseline in number of regulatory T-cells at 22 weeks [Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
Change from baseline in number of regulatory T-cells at 6 weeks [Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
Secondary Outcome(s)
Change from baseline in CD161 expression at 22 weeks [Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
Change from baseline in CD161 expression at 6 weeks [Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
Change from baseline in cytokine levels at 22 weeks [Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
Change from baseline in cytokine levels at 6 weeks [Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
Change from baseline in Harvey Bradshaw Index at 22 weeks [Time Frame: Baseline, 22 weeks (plus/minus 1 week)]
Change from baseline in Harvey Bradshaw Index at 6 weeks [Time Frame: Baseline, 6 weeks (plus/minus 1 week)]
Secondary ID(s)
H-1-2013-072
HVH-2013-028
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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