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

2017年7月27日更新者：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.

調査の概要

状態

完了

条件

関節炎、リウマチ

介入・治療

研究の種類

介入

入学 (実際)

段階

フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

イギリス
- - Oxford、イギリス、OX3 7LP
    - GSK Investigational Site
  - Sheffield、イギリス、S10 2RX
    - GSK Investigational Site
- Cambridgeshire
  - Cambridge、Cambridgeshire、イギリス、CB2 0QQ
    - GSK Investigational Site
- Lancashire
  - Wigan、Lancashire、イギリス、WN6 9EP
    - GSK Investigational Site
- Merseyside
  - Liverpool、Merseyside、イギリス、L9 7AL
    - GSK Investigational Site
- Northumberland
  - Newcastle、Northumberland、イギリス、NE1 4LP
    - GSK Investigational Site
オーストラリア
- New South Wales
  - Darlinghurst、New South Wales、オーストラリア、2010
    - GSK Investigational Site
- Queensland
  - Douglas、Queensland、オーストラリア、4814
    - GSK Investigational Site
  - Woolloongabba、Queensland、オーストラリア、4102
    - GSK Investigational Site
- South Australia
  - Daw Park、South Australia、オーストラリア、5041
    - GSK Investigational Site
  - Woodville、South Australia、オーストラリア、5011
    - GSK Investigational Site
- Tasmania
  - Hobart、Tasmania、オーストラリア、7000
    - GSK Investigational Site
- Western Australia
  - Shenton Park、Western Australia、オーストラリア、6008
    - GSK Investigational Site
ドイツ
- - Berlin、ドイツ、14059
    - GSK Investigational Site
  - Berlin、ドイツ、13125
    - GSK Investigational Site
  - Berlin、ドイツ、14109
    - GSK Investigational Site
  - Berlin、ドイツ、12163
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Villingen-Schwenningen、Baden-Wuerttemberg、ドイツ、78054
    - GSK Investigational Site
- Niedersachsen
  - Hildesheim、Niedersachsen、ドイツ、31134
    - GSK Investigational Site
- Sachsen
  - Chemnitz、Sachsen、ドイツ、09111
    - GSK Investigational Site
  - Leipzig、Sachsen、ドイツ、04107
    - GSK Investigational Site
  - Leipzig、Sachsen、ドイツ、04229
    - GSK Investigational Site
フランス
- - Montpellier Cedex 5、フランス、34295
    - GSK Investigational Site
- Picardie
  - Amiens、Picardie、フランス、80054
    - GSK Investigational Site
ロシア連邦
- - Ekaterinburg、ロシア連邦、620102
    - GSK Investigational Site
  - Moscow、ロシア連邦、115522
    - GSK Investigational Site
  - Ryazan、ロシア連邦、390026
    - GSK Investigational Site
  - Yaroslavl、ロシア連邦、150003
    - GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323 時間枠：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)

二次結果の測定

結果測定	メジャーの説明	時間枠
Analysis of CRP levels 24 and 48 hours post-dose following SB-681323 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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) 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2005年6月21日

一次修了 (実際)

2006年8月3日

研究の完了 (実際)

2006年8月3日

試験登録日

最初に提出

2005年8月24日

QC基準を満たした最初の提出物