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

2018년 9월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

15

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
개입 / 치료
Infliximab 5 mg/kg
Infliximab treatment and endoscopy.
의약품: Infliximab
Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
다른 이름들:
  • 레미케이드
  • SCH 215596
  • MK-2155

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 11월 28일

기본 완료 (실제)

2015년 9월 28일

연구 완료 (실제)

2015년 9월 28일

연구 등록 날짜

최초 제출

2011년 5월 5일

QC 기준을 충족하는 최초 제출

2011년 5월 6일

처음 게시됨 (추정)

2011년 5월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 14일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Infliximab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mauritius

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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