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Completed

NCT Number: NCT02060318

Regulatory T-cells and Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change from baseline in Harvey Bradshaw Index at 6 weeks

    Time frame: Baseline, 6 weeks (plus/minus 1 week)

    Harvey Bradshaw Index is a measure of Crohn's Disease severity.

  2. Change from baseline in CD161 expression at 6 weeks

    Time frame: Baseline, 6 weeks (plus/minus 1 week)

    Cluster of differentiation 161 (CD161) is a T helper 17 cell (Th17)-marker, measured by flow cytometry of fresh blood samples.

  3. Change from baseline in CD161 expression at 22 weeks

    Time frame: Baseline, 22 weeks (plus/minus 1 week)

    CD161 is a Th17-marker, measured by flow cytometry of fresh blood samples.

  4. Change from baseline in cytokine levels at 6 weeks

    Time frame: Baseline, 6 weeks (plus/minus 1 week)

    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.

  5. Change from baseline in cytokine levels at 22 weeks

    Time frame: Baseline, 22 weeks (plus/minus 1 week)

    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.

  6. Change from baseline in Harvey Bradshaw Index at 22 weeks

    Time frame: Baseline, 22 weeks (plus/minus 1 week)

    Harvey Bradshaw Index is a measure of Crohn's Disease severity.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells

Acronym: CrohnReg

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2014
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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