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Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

14. september 2018 opdateret af: Merck Sharp & Dohme LLC

An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)

This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy with infliximab and determine whether changes in the levels of the selected biomarkers can be used to predict endoscopically assessed gut mucosal status changes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

15

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 til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
  • History of colonic involvement verified by prior endoscopy or radiography
  • Indicated for treatment with infliximab according to current best medical practice
  • Body Mass Index (BMI) between 15 kg/m^2 and 35 kg/m^2
  • Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception
  • Negative pregnancy test
  • No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration

Exclusion Criteria:

  • Pregnancy, intention to become pregnant, or breastfeeding
  • Evidence of a colon unaffected by CD
  • Indication for surgery
  • Perianal disease likely to interfere with study participation
  • Presence of a stoma or history of colectomy
  • Symptomatic diarrhea unrelated to CD
  • Strictures or evidence of bowel obstruction
  • Presence of abscess unless completed definitive treatment can be documented one week prior to screening
  • Presence of fistulas
  • Contraindication to infliximab
  • Intolerance to sedatives or other medications required for endoscopy
  • Any prior use of anti-inflammatory biologic therapy
  • Moderate or severe congestive heart failure
  • History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
  • Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening
  • Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)
  • History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix
  • History of systemic granulomatous infection
  • History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry
  • Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Infliximab 5 mg/kg
Infliximab treatment and endoscopy.
Medicin: Infliximab
Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
Andre navne:
  • Remicade
  • SCH 215596
  • MK-2155

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
Tidsramme: Baseline and Week 6
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Baseline and Week 6
Change From Baseline in CDEIS Blinded Score at Week 22
Tidsramme: Baseline and Week 22
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Baseline and Week 22
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6
Tidsramme: Baseline and Week 6
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Baseline and Week 6
Change From Baseline in Serum hsCRP at Week 22
Tidsramme: Baseline and Week 22
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Baseline and Week 22
Change From Baseline in Stool Calprotectin at Week 6
Tidsramme: Baseline and Week 6
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Baseline and Week 6
Change From Baseline in Stool Calprotectin at Week 22
Tidsramme: Baseline and Week 22
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Baseline and Week 22
Change From Baseline in Serum Lipocalin-2 at Week 6
Tidsramme: Baseline and Week 6
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Baseline and Week 6
Change From Baseline in Serum Lipocalin-2 at Week 22
Tidsramme: Baseline and Week 22
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Baseline and Week 22
Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6
Tidsramme: Baseline and Week 6
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Baseline and Week 6
Change From Baseline in REG3-A at Week 22
Tidsramme: Baseline and Week 22
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Baseline and Week 22
Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
Tidsramme: Baseline and Week 6 or 22
To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.
Baseline and Week 6 or 22

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
Tidsramme: Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)
Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
Tidsramme: Baseline, Week 6, Week 22
The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Baseline, Week 6, Week 22

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

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)

28. november 2012

Primær færdiggørelse (Faktiske)

28. september 2015

Studieafslutning (Faktiske)

28. september 2015

Datoer for studieregistrering

Først indsendt

5. maj 2011

Først indsendt, der opfyldte QC-kriterier

6. maj 2011

Først opslået (Skøn)

9. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P08143
  • 2011-000517-40 (EudraCT nummer)
  • MK-2155-195

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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

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Betingelser

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Placeringer

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