Regulatory T-cells and Crohn's Disease

NCT02060318 | Completed

• 2 other identifiers: H-1-2013-072HVH-2013-028
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crohn Disease

Keywords

Crohn Disease; Regulatory T-cells; Infliximab

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 22 weeks (plus/minus 1 week)

Secondary Outcomes (6)

• Change from baseline in Harvey Bradshaw Index at 6 weeks

  Baseline, 6 weeks (plus/minus 1 week)

• Change from baseline in CD161 expression at 6 weeks

  Baseline, 6 weeks (plus/minus 1 week)

• Change from baseline in CD161 expression at 22 weeks

  Baseline, 22 weeks (plus/minus 1 week)

• Change from baseline in cytokine levels at 6 weeks

  Baseline, 6 weeks (plus/minus 1 week)

• Change from baseline in cytokine levels at 22 weeks

  Baseline, 22 weeks (plus/minus 1 week)

Study Arms (2)

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.

Drug: Infliximab

Healthy controls

12 healthy controls without Crohn's Disease.

Interventions

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.

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Crohn's Disease
• Starting Infliximab treatment
• Patient at the gastrointestinal department at Hvidovre Hospital or Køge Sygehus
• Can understand and write Danish
• European ancestry

You may not qualify if:

• 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
• No current disease
• No daily drug use
• Can understand and write Danish
• European ancestry
• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, peripheral blood mononuclear cells.

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ove Andersen, MD, PhD

  Hvidovre Hospital & University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: February 11, 2014
• Primary Completion: March 7, 2016
• Study Completion: March 7, 2016
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

DK (1)