Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
연구 개요
상세 설명
The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:
Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.
Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.
Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.
Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.
Exploratory objectives:
Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).
Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.
This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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London, 영국
- Guy's & St Thomas' NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- Moderate-to-severe UC, defined as:
SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- Imminent need for colectomy (i.e. colectomy is being planned)
- Previous primary non-response to anti-TNF therapy in the opinion of the investigator
- Previous treatment with more than one anti-TNF therapy (excluding golimumab)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Induction cohort
Golimumab induction therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
다른 이름들:
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다른: Maintenance cohort
Golimumab maintenance therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum Golimumab Concentration (μg/ml)
기간: Week 6 during induction therapy and at the point of study entry during maintenance
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Evaluated using an enzyme-linked immunosorbent assay (ELISA)
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Week 6 during induction therapy and at the point of study entry during maintenance
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Patients in Clinical Remission
기간: Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Faecal Calprotectin (μg/g)
기간: Week 14 during induction therapy and at the point of study entry during maintenance
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Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum C-Reactive Protein (mg/L)
기간: Week 14 during induction therapy and at the point of study entry during maintenance
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Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum Albumin (g/L)
기간: Week 14 during induction therapy and at the point of study entry during maintenance
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Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
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Week 14 during induction therapy and at the point of study entry during maintenance
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Clinical UC Disease Activity
기간: Week 14 during maintenance therapy and at the point of study entry during maintenance
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Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
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Week 14 during maintenance therapy and at the point of study entry during maintenance
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Quality of Life (IBD-Control)
기간: Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Number of Patients With Detectable Anti-golimumab Antibodies
기간: At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
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At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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