Regulatory T-cells and Crohn's Disease

NCT ID: NCT02060318

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-11
• Study Completion Date: 2016-03-07

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Infliximab

Intervention Type: 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.

Healthy controls

12 healthy controls without Crohn's Disease.

No interventions assigned to this group

Interventions

Infliximab

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.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

Healthy controls

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ove Andersen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ove Andersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Hospital & University of Copenhagen

Locations

Hvidovre Hospital

Hvidovre, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

HVH-2013-028

Identifier Type: REGISTRY

Identifier Source: secondary_id

H-1-2013-072

Identifier Type: -

Identifier Source: org_study_id