이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

2017년 2월 28일 업데이트: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

84

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 그리스
      • Thessaloniki, 그리스
        • Novartis Investigative Site
  • 남아프리카
      • Pretoria, 남아프리카
        • Novartis Investigative Site
    • Durban
      • Berea, Durban, 남아프리카
        • Novartis Investigative Site
      • Mayville, Durban, 남아프리카
        • Novartis Investigative Site
  • 네덜란드
      • Utrecht, 네덜란드
        • Novartis Investigative Site
  • 노르웨이
      • Oslo, 노르웨이
        • Novartis Investigative Site
  • 덴마크
      • Arhus N, 덴마크
        • Novartis Investigative Site
  • 독일
      • Bad Bamstedt, 독일
        • Novartis Investigative Site
      • Berlin, 독일
        • Novartis Investigative Site
      • Bremen, 독일
        • Novartis Investigative Site
      • Dresden, 독일
        • Novartis Investigative Site
      • Freiburg, 독일
        • Novartis Investigative Site
      • Garmisch-Partenkirch, 독일
        • Novartis Investigative Site
      • Geissen, 독일
        • Novartis Investigative Site
      • Hamburg, 독일
        • Novartis Investigative Site
      • Hannover, 독일
        • Novartis Investigative Site
      • Krefeld, 독일
        • Novartis Investigative Site
      • Mainz, 독일
        • Novartis Investigative Site
      • Muenster, 독일
        • Novartis Investigative Site
      • Saint Augustin, 독일
        • Novartis Investigative Site
      • Stuttgart, 독일
        • Novartis Investigative Site
      • Tubingen, 독일
        • Novartis Investigative Site
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, 미국, 72202
        • Arkansas Children's Hospital Research Inst
    • California
      • Los Angeles, California, 미국, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington, District of Columbia, 미국, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, 미국, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, 미국, 02111
        • Tufts New England Medical Center-Dept. of Allergy
    • New Jersey
      • Livingston, New Jersey, 미국, 07039
        • St. Barnabas Ambulatory Care Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45229
        • Children's Hospital Medical Center
      • Cinncinati, Ohio, 미국, 45229
        • Children's Hospital/Neurology
      • Columbus, Ohio, 미국, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, 미국, 97227
        • Legacy Emanuel Hospital
      • Portland, Oregon, 미국, 97232
        • Legacy Emanual Research
    • Texas
      • Austin, Texas, 미국, 78723
        • Specially For Children
  • 벨기에
      • Bruxelles, 벨기에
        • Novartis Investigative Site
      • Gent, 벨기에
        • Novartis Investigative Site
      • Laeken, 벨기에
        • Novartis Investigative Site
      • Leuven, 벨기에
        • Novartis Investigative Site
  • 브라질
      • Curitiba, 브라질
        • Novartis Investigative Site
      • Porto Alegre, 브라질
        • Novartis Investigative Site
      • Rio de Janeiro, 브라질
        • Novartis Investigative Site
      • Sao Paulo, 브라질
        • Novartis Investigative Site
  • 스웨덴
      • Stockholm, 스웨덴
        • Novartis Investigative Site
  • 스위스
      • Bern, 스위스
        • Novartis Investigative Site
      • Lausanne, 스위스
        • Novartis Investigative Site
      • Zurich, 스위스
        • Novartis Investigative Site
  • 스페인
      • Barcelona, 스페인
        • Novartis Investigative Site
      • Madrid, 스페인
        • Novartis Investigative Site
      • Valencia, 스페인
        • Novartis Investigative Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나
        • Novartis Investigative Site
      • Capital Federal, 아르헨티나
        • Novartis Investigative Site
      • La Plata, 아르헨티나
        • Novartis Investigative Site
  • 영국
      • Birmingham, 영국
        • Novartis Investigative Site
      • Liverpool, 영국
        • Novartis Investigative Site
      • London, 영국
        • Novartis Investigative Site
      • Manchester, 영국
        • Novartis Investigative Site
      • New Castle Upon Tyne, 영국
        • Novartis Investigative Site
      • Norwich, 영국
        • Novartis Investigative Site
      • Oxford, 영국
        • Novartis Investigative Site
  • 이스라엘
      • Haifa, 이스라엘
        • Novartis Investigative Site
      • Kfar Saba, 이스라엘
        • Novartis Investigative Site
      • Petach-Tikva, 이스라엘
        • Novartis Investigative Site
      • Ramat Gan, 이스라엘
        • Novartis Investigative Site
      • Rehovot, 이스라엘
        • Novartis Investigative Site
  • 이탈리아
      • Bologna, 이탈리아
        • Novartis Investigative Site
      • Firenze, 이탈리아
        • Novartis Investigative Site
      • Genova, 이탈리아
        • Novartis Investigative Site
      • Milano, 이탈리아
        • Novartis Investigative Site
      • Napoli, 이탈리아
        • Novartis Investigative Site
      • Padova, 이탈리아
        • Novartis Investigative Site
      • Rome, 이탈리아
        • Novartis Investigative Site
      • Scafati, 이탈리아
        • Novartis Investigative Site
      • Torino, 이탈리아
        • Novartis Investigative Site
  • 칠면조
      • Ankara, 칠면조
        • Novartis Investigative Site
      • Istanbul, 칠면조
        • Novartis Investigative Site
      • Izmir, 칠면조
        • Novartis Investigative Site
  • 캐나다
      • Calgary, 캐나다
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, 캐나다
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, 캐나다
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, 캐나다
        • Novartis Investigative Site
  • 페루
      • Lima, 페루
        • Novartis Investigative Site
  • 폴란드
      • Warszawa, 폴란드
        • Novartis Investigative Site
  • 프랑스
      • Le Kremlin Bicetre, 프랑스
        • Novartis Investigative Site
      • Lyon, 프랑스
        • Novartis Investigative Site
      • Paris, 프랑스
        • Novartis Investigative Site
      • Strassbourg, 프랑스
        • Novartis Investigative Site
  • 헝가리
      • Budapest, 헝가리
        • Novartis Investigative 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

2년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age:

    • Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following:
    • evanescent nonfixed erythematous rash,
    • generalized lymph node enlargement,
    • hepatomegaly and/ or splenomegaly,
    • serositis
  2. Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
  3. Male and female patients aged ≥ 2 to < 20 years of age

  4. Active disease at the time of enrollment defined as follows:

    • At least 2 joints with active arthritis
    • Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
    • C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
  5. Naïve to canakinumab
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:

  1. Pregnant or nursing (lactating) female patients
  2. Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
  3. History of hypersensitivity to study drug or to biologics.
  4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
  5. With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
  6. Other protocol defined exclusion criteria may apply

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Canakinumab
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
의약품: Canakinumab
Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
다른 이름들:
  • ACZ885
위약 비교기: Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
의약품: Placebo
Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
기간: Baseline, Day 15, Day 29
Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Baseline, Day 15, Day 29

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
기간: Baseline, Day 15, Day 29
Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 70
기간: Baseline, Day 15, Day 29
Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 90
기간: Baseline, Day 15, Day 29
Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 100
기간: baseline, Day 15, Day 29
Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
baseline, Day 15, Day 29
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)
기간: Baseline, Day 15
CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Baseline, Day 15
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ
기간: Baseline, Day 29
CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Baseline, Day 29
Percentage of Patients Who Had Body Temperature ≤ 38°C
기간: Day 3
Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.
Day 3
Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
기간: Over 4 week study period (Baseline, Day 15, Day 29)
CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
Over 4 week study period (Baseline, Day 15, Day 29)
Change in Disability Score Over Time by Use of the CHAQ
기간: At 4 week study period
The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.
At 4 week study period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

협력자

International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Southwest Pediatric Nephrology Study Group

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

2009년 7월 1일

기본 완료 (실제)

2010년 12월 1일

연구 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

2009년 4월 22일

QC 기준을 충족하는 최초 제출

2009년 4월 22일

처음 게시됨 (추정)

2009년 4월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 28일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CACZ885G2305
  • EudraCT: 2008-005476-27

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. .

Canakinumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Denmark

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다