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Regulatory T-cells and Crohn's Disease (CrohnReg)

31. august 2017 opdateret af: Ove Andersen, Hvidovre University Hospital

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

47

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
    • Copenhagen
      • Hvidovre, Copenhagen, Danmark, 2650
        • Hvidovre Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients from the gastroenterology department at Hvidovre Hospital and Køge Sygehus are eligible for entry.

Healthy controls are recruited by advitising at Hvidovre Hospital.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: 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.
Healthy controls
12 healthy controls without Crohn's Disease.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in number of regulatory T-cells at 6 weeks
Tidsramme: Baseline, 6 weeks (plus/minus 1 week)
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
Tidsramme: Baseline, 22 weeks (plus/minus 1 week)
The number of regulatory T-cells is measured in fresh blood by flow cytometry.
Baseline, 22 weeks (plus/minus 1 week)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Harvey Bradshaw Index at 6 weeks
Tidsramme: Baseline, 6 weeks (plus/minus 1 week)
Harvey Bradshaw Index is a measure of Crohn's Disease severity.
Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in CD161 expression at 6 weeks
Tidsramme: 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.
Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in CD161 expression at 22 weeks
Tidsramme: Baseline, 22 weeks (plus/minus 1 week)
CD161 is a Th17-marker, measured by flow cytometry of fresh blood samples.
Baseline, 22 weeks (plus/minus 1 week)
Change from baseline in cytokine levels at 6 weeks
Tidsramme: 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.
Baseline, 6 weeks (plus/minus 1 week)
Change from baseline in cytokine levels at 22 weeks
Tidsramme: 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.
Baseline, 22 weeks (plus/minus 1 week)
Change from baseline in Harvey Bradshaw Index at 22 weeks
Tidsramme: Baseline, 22 weeks (plus/minus 1 week)
Harvey Bradshaw Index is a measure of Crohn's Disease severity.
Baseline, 22 weeks (plus/minus 1 week)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hvidovre University Hospital

Efterforskere

  • Ledende efterforsker: Ove Andersen, MD, PhD, Hvidovre Hospital & University of Copenhagen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. februar 2014

Primær færdiggørelse (Faktiske)

7. marts 2016

Studieafslutning (Faktiske)

7. marts 2016

Datoer for studieregistrering

Først indsendt

10. februar 2014

Først indsendt, der opfyldte QC-kriterier

10. februar 2014

Først opslået (Skøn)

12. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-1-2013-072
  • HVH-2013-028 (Registry Identifier: Datatilsynet)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Crohns sygdom

Kliniske forsøg med Infliximab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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