Crohn DiseaseCrohnRegNCT02060318
Regulatory T-cells and Crohn's Disease
An observational study of Crohn Disease, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17 cells and other immune cell types) or biomarkers can be used to predict the response or lack of response to treatment with Infliximab. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Feb 2014to 7 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the gastroenterology department at Hvidovre Hospital and Køge Sygehus are eligible for entry. Healthy controls are recruited by advitising at Hvidovre Hospital.
Who may be able to join
- Crohn's Disease
- Starting Infliximab treatment
- Patient at the gastrointestinal department at Hvidovre Hospital or Køge Sygehus
- Can understand and write Danish
- European ancestry
- No current disease
Show all 9Show fewer
- No daily drug use
- Can understand and write Danish
- European ancestry
Who cannot join
- 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
- Not able to consent in an ethical manner (e.g. severe mental illness)
Show all 9Show fewer
- Significant co-morbidity (e.g. cancer, HIV)
- Other immunological disease (e.g. psoriasis)
- Current treatment with biological agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells
Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17 cells and other immune cell types) or biomarkers can be used to predict the response or lack of response to treatment with Infliximab. If so, characteristics of the immune cells may also unveil the mechanisms behind lack of response to Infliximab.
Design: a prospective, observational study with three arms. In the treatment group, 35 patients with Crohn's disease about to start Infliximab-treatment are recruited. They have blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines, and data from this study is not used by the clinicians.
Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is investigated using flow cytometry. From plasma and serum samples, various proteins (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical history) are extracted from various registries.
Read the detailed description
Primary analyses: patient response to Infliximab treatment is quantified using Harvey Bradshaw Index, and the response is then related to the number of regulatory T-cells, Th17 cells, and biomarker levels at baseline. The exact cut-off for response vs. non-respons will be determined and validated once all data is collected by an assessor blinded for the flow cytometry results and biomarker levels.
Plan for missing data: for patients with missing Harvey Bradshaw Index, we will first try to re-create the score using the patient records (information on well-being, abdominal pain, diarrhea, fistulae/abscesses, and extra-intestinal Crohn manifestations). If this is not possible, an experienced clinician will rate the patient's Infliximab response based on all available patient record data, but blinded for flow cytometry results and biomarker levels.
- Conditions
- Crohn Disease
- Being tested
- Infliximab
- Keywords
- Crohn Disease, Regulatory T-cells, Infliximab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
The patients are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | 35 Crohn patients about to start Infliximab treatment, gives as i.v. injection of 5 mg/kg at baseline, after 2 weeks, 6 weeks, and then every 8th week. Receives: Drug: Infliximab | |
| Healthy controls | 12 healthy controls without Crohn's Disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of regulatory T-cells at 6 weeks
The number of regulatory T-cells is measured in fresh blood by flow cytometry.
Measured: Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in number of regulatory T-cells at 22 weeks
The number of regulatory T-cells is measured in fresh blood by flow cytometry.
Measured: Baseline, 22 weeks (plus/minus 1 week)
Secondary outcomes (6)
Change from baseline in Harvey Bradshaw Index at 6 weeks
Harvey Bradshaw Index is a measure of Crohn's Disease severity.
Measured: Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in CD161 expression at 6 weeks
Cluster of differentiation 161 (CD161) is a T helper 17 cell (Th17)-marker, measured by flow cytometry of fresh blood samples.
Measured: Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in CD161 expression at 22 weeks
CD161 is a Th17-marker, measured by flow cytometry of fresh blood samples.
Measured: Baseline, 22 weeks (plus/minus 1 week)
Change from baseline in cytokine levels at 6 weeks
We will measure IFN-gamma, IL-4, IL-6, IL-7, IL-10, IL-15, IL-17, and TNF-alpha by Luminex. TGF-beta, suPAR, and IL-15 will be measured by ELISA.
Measured: Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in cytokine levels at 22 weeks
We will measure IFN-gamma, IL-4, IL-6, IL-7, IL-10, IL-15, IL-17, and TNF-alpha by Luminex. TGF-beta, suPAR, and IL-15 will be measured by ELISA.
Measured: Baseline, 22 weeks (plus/minus 1 week)
Change from baseline in Harvey Bradshaw Index at 22 weeks
Harvey Bradshaw Index is a measure of Crohn's Disease severity.
Measured: Baseline, 22 weeks (plus/minus 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start11 Feb 2014
- Primary completion7 Mar 2016
- Study completion7 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, MD, PhD, Principal investigator, Hvidovre Hospital & University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060318
- Sponsor's protocol ID
- H-1-2013-072
- Other IDs
- HVH-2013-028
- Acronym
- CrohnReg
- Status last verified
- Aug 2017
- First submitted
- 10 Feb 2014
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells
- ClinicalTrials.gov ID
- NCT02060318
- Acronym / sponsor ID
- CrohnReg / H-1-2013-072
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Regulatory T-cells, Infliximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 7 Mar 2016 (actual)
- Study completion
- 7 Mar 2016 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17 cells and other immune cell types) or biomarkers can be used to predict the response or lack of response to treatment with Infliximab. If so, characteristics of the immune cells may also unveil the mechanisms behind lack of response to Infliximab.
Design: a prospective, observational study with three arms. In the treatment group, 35 patients with Crohn's disease about to start Infliximab-treatment are recruited. They have blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines, and data from this study is not used by the clinicians.
Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is investigated using flow cytometry. From plasma and serum samples, various proteins (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical history) are extracted from various registries.
Detailed description
Primary analyses: patient response to Infliximab treatment is quantified using Harvey Bradshaw Index, and the response is then related to the number of regulatory T-cells, Th17 cells, and biomarker levels at baseline. The exact cut-off for response vs. non-respons will be determined and validated once all data is collected by an assessor blinded for the flow cytometry results and biomarker levels.
Plan for missing data: for patients with missing Harvey Bradshaw Index, we will first try to re-create the score using the patient records (information on well-being, abdominal pain, diarrhea, fistulae/abscesses, and extra-intestinal Crohn manifestations). If this is not possible, an experienced clinician will rate the patient's Infliximab response based on all available patient record data, but blinded for flow cytometry results and biomarker levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | Drug: Infliximab35 Crohn patients about to start Infliximab treatment, gives as i.v. injection of 5 mg/kg at baseline, after 2 weeks, 6 weeks, and then every 8th week. |
| Healthy controls | – | –12 healthy controls without Crohn's Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the gastroenterology department at Hvidovre Hospital and Køge Sygehus are eligible for entry. Healthy controls are recruited by advitising at Hvidovre Hospital.
Key inclusion criteria (9 listed)
- Crohn's Disease
- Starting Infliximab treatment
- Patient at the gastrointestinal department at Hvidovre Hospital or Køge Sygehus
- Can understand and write Danish
- European ancestry
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabThe patients are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines. | Drug | Infliximab |
Primary outcome
Change from baseline in number of regulatory T-cells at 6 weeks
Time frame: Baseline, 6 weeks (plus/minus 1 week)
The number of regulatory T-cells is measured in fresh blood by flow cytometry.
Change from baseline in number of regulatory T-cells at 22 weeks
Time frame: Baseline, 22 weeks (plus/minus 1 week)
The number of regulatory T-cells is measured in fresh blood by flow cytometry.
6 secondary outcomes
Change from baseline in Harvey Bradshaw Index at 6 weeks
Time frame: Baseline, 6 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 CD161 expression 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 cytokine levels at 22 weeks
Time frame: Baseline, 22 weeks (plus/minus 1 week)
Change from baseline in Harvey Bradshaw Index at 22 weeks
Time frame: Baseline, 22 weeks (plus/minus 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: Undecided. Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ove Andersen, MD, PhD principal investigator
Hvidovre Hospital & University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in number of regulatory T-cells at 6 weeks (time frame: Baseline, 6 weeks (plus/minus 1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.