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A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

2017년 7월 27일 업데이트: GlaxoSmithKline

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

연구 개요

상태

완전한

정황

관절염, 류마티스

개입 / 치료

연구 유형

중재적

등록 (실제)

단계

2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

독일
- - Berlin, 독일, 14059
    - GSK Investigational Site
  - Berlin, 독일, 13125
    - GSK Investigational Site
  - Berlin, 독일, 14109
    - GSK Investigational Site
  - Berlin, 독일, 12163
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Villingen-Schwenningen, Baden-Wuerttemberg, 독일, 78054
    - GSK Investigational Site
- Niedersachsen
  - Hildesheim, Niedersachsen, 독일, 31134
    - GSK Investigational Site
- Sachsen
  - Chemnitz, Sachsen, 독일, 09111
    - GSK Investigational Site
  - Leipzig, Sachsen, 독일, 04107
    - GSK Investigational Site
  - Leipzig, Sachsen, 독일, 04229
    - GSK Investigational Site
러시아 연방
- - Ekaterinburg, 러시아 연방, 620102
    - GSK Investigational Site
  - Moscow, 러시아 연방, 115522
    - GSK Investigational Site
  - Ryazan, 러시아 연방, 390026
    - GSK Investigational Site
  - Yaroslavl, 러시아 연방, 150003
    - GSK Investigational Site
영국
- - Oxford, 영국, OX3 7LP
    - GSK Investigational Site
  - Sheffield, 영국, S10 2RX
    - GSK Investigational Site
- Cambridgeshire
  - Cambridge, Cambridgeshire, 영국, CB2 0QQ
    - GSK Investigational Site
- Lancashire
  - Wigan, Lancashire, 영국, WN6 9EP
    - GSK Investigational Site
- Merseyside
  - Liverpool, Merseyside, 영국, L9 7AL
    - GSK Investigational Site
- Northumberland
  - Newcastle, Northumberland, 영국, NE1 4LP
    - GSK Investigational Site
프랑스
- - Montpellier Cedex 5, 프랑스, 34295
    - GSK Investigational Site
- Picardie
  - Amiens, Picardie, 프랑스, 80054
    - GSK Investigational Site
호주
- New South Wales
  - Darlinghurst, New South Wales, 호주, 2010
    - GSK Investigational Site
- Queensland
  - Douglas, Queensland, 호주, 4814
    - GSK Investigational Site
  - Woolloongabba, Queensland, 호주, 4102
    - GSK Investigational Site
- South Australia
  - Daw Park, South Australia, 호주, 5041
    - GSK Investigational Site
  - Woodville, South Australia, 호주, 5011
    - GSK Investigational Site
- Tasmania
  - Hobart, Tasmania, 호주, 7000
    - GSK Investigational Site
- Western Australia
  - Shenton Park, Western Australia, 호주, 6008
    - GSK Investigational Site

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria:

Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
Must have 3 or more swollen or 3 or more tender/painful joints at screening.
Must be on stable weekly methotrexate (2.5mg - 25mg) for at least eight weeks prior to screening.

Exclusion criteria:

Must not be morbidly obese.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 더블

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323 기간: Day 3 (at 72 hour)	CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.	Day 3 (at 72 hour)

2차 결과 측정

결과 측정	측정값 설명	기간
Analysis of CRP levels 24 and 48 hours post-dose following SB-681323 기간: Day 1 (at 24 hour) and Day 2 (at 48 hour)	CRP levels were compared between SB-681323 and placebo 24 and 48 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.	Day 1 (at 24 hour) and Day 2 (at 48 hour)
Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323 기간: Upto Day 3 (at 1, 3, 24 and 72 hour)	A blood sample of approximately 5 milliliter (mL) was taken for measurement of serum markers. IL-6 measurements were performed at 1 hour, 3, hours, 24 hours and 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.	Upto Day 3 (at 1, 3, 24 and 72 hour)
Number of participants with adverse events (AE) and serious adverse events (SAE) 기간: Upto Day 3 (72 hours)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. There were no SAEs reported in this study.	Upto Day 3 (72 hours)
Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP) 기간: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)	Supine vital signs SBP and DBP were recorded whilst the participant was in a supine position (participant lying flat with maximum one pillow) having rested in that position for at least 10 minutes before each reading. Measurements were performed at 90 minutes, 3 hours, 24 hours and 72 hours post-dose. Baseline was defined as assessment performed pre-dose at Day 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values at the time of assessment.	Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Change from Baseline in vital sign heart rate 기간: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)	Supine vital signs (heart rate) was recorded whilst the participant was in a supine position (participant lying flat with maximum one pillow) having rested in that position for at least 10 minutes before each reading. Measurements were performed at 90 minutes, 3 hours, 24 hours and 72 hours post-dose. Baseline was defined as assessment performed pre-dose at Day 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values at the time of assessment.	Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Number of participants with abnormal electrocardiogram (ECG) findings 기간: Day 1 (pre-dose, 1 hour and 3 hour)	Full 12-lead ECGs were recorded using an ECG machine that automatically calculated the pulse rate and measured PR, RR, QRS, QT, QTc(b) intervals (Bazett's correction was applied to QTc measurements). Measurements were carried out at pre-dose, 1 hour and 3 hours on Day 1. ECG findings were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). Data has been presented for A-NCS findings on Day 1.	Day 1 (pre-dose, 1 hour and 3 hour)
Number of participants with clinical chemistry data outside the clinical concern range 기간: Upto Day 3 (pre-dose, 24, 48 and 72 hours	Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, indirect bilirubin, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, potassium, lactate dehydrogenase, triglycerides. Measurements were carried out at pre-dose, 24 hours, 48 hours and 72 hours. Data for number of participants with values outside clinical concern range defined as high and low have been presented.	Upto Day 3 (pre-dose, 24, 48 and 72 hours
Number of participants with hematology data outside the clinical concern 기간: Upto Day 3 (pre-dose, 24 and 72 hours)	Hematology parameters included eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin, mean corpuscle volume, platelet count, reticulocytes, white blood cell count (WBC). Measurements were carried out at pre-dose, 24 hours and 72 hours. Data for number of participants with values outside clinical concern range defined as high and low have been presented.	Upto Day 3 (pre-dose, 24 and 72 hours)
Number of participants with abnormal urinalysis dipstick results 기간: Upto Day 3 (pre-dose, 24 and 72 hours)	Approximately 10-20 mL mid-stream urine was collected into a sterile container and was screened by dipstick for: occult blood, proteins, ketones, glucose, red blood cells (RBC) and WBC. Sediment microscopy was performed only if any of the Multi-stick tests were abnormal. In such cases, microscopy was performed for: WBC, RBC, hyaline casts, granular casts, cellular casts. Data for number of participants with abnormal urinalysis results for positive parameters as assessed by dipstick and microscopic analysis have been presented.	Upto Day 3 (pre-dose, 24 and 72 hours)
Whole blood messenger RNA (mRNA) levels of tumor necrosis factor alpha [TNF-α], IL-8, IL-1β and Cyclo-oxygenase-2 [COX-2] (and other genes implicated in the pathogenesis of RA or genes involved in the mode of action of the compounds administered) 기간: Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1	Blood samples were taken for extraction of whole blood mRNA (2 x 2.5mL PAXgene tubes). The samples were taken at the time-points pre-dose, 45 minutes, 90 minutes and 3 hours. Messenger RNA levels for various markers was measured. These markers included Prednisolone markers: DDIT4, DUSP1, FKBP5, GILZ, IL1R2, TXNIP, ZNF145 and p38 markers: COX2, IFI30, IL1b, IL6, IL8, TNF. An aliquot of mRNA was stored for later analysis of other genes associated with the pathogenesis of RA and in the mode of action of the compounds administered.	Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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)

2005년 6월 21일

기본 완료 (실제)

2006년 8월 3일

연구 완료 (실제)

2006년 8월 3일

연구 등록 날짜

최초 제출

2005년 8월 24일

QC 기준을 충족하는 최초 제출