A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)
2017년 5월 16일 업데이트: Hoffmann-La Roche
A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
연구 개요
연구 유형
중재적
등록 (실제)
52
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, 13353
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Freiburg, 독일, 79106
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Sankt Augustin, 독일, 53757
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Moscow, 러시아 연방, 115522
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Moscow, 러시아 연방, 119991
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Monterrey, 멕시코, 64460
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Connecticut
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Hartford, Connecticut, 미국, 06106
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Illinois
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Chicago, Illinois, 미국, 60637
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Chicago, Illinois, 미국, 60611
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New Jersey
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Hackensack, New Jersey, 미국, 07601
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North Carolina
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Charlotte, North Carolina, 미국, 28203
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Durham, North Carolina, 미국, 27710
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Ohio
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Cincinnati, Ohio, 미국, 45229-3039
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Oklahoma
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Tulsa, Oklahoma, 미국, 74135
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Utah
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Salt Lake City, Utah, 미국, 84109
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Washington
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Seattle, Washington, 미국, 98105
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RJ
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Rio de Janeiro, RJ, 브라질, 20551-030
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Rio de Janeiro, RJ, 브라질, 21941-912
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SP
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Sao Paulo, SP, 브라질, 05403-000
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Sao Paulo, SP, 브라질, 22793-080
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Madrid, 스페인, 28046
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Madrid, 스페인, 28034
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Barcelona
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Esplugas de Llobregat, Barcelona, 스페인, 08950
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Buenos Aires, 아르헨티나, 1270
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Bristol, 영국, BS2 8BJ
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Liverpool, 영국, L12 2AP
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Lazio
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Roma, Lazio, 이탈리아, 00165
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Liguria
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Genova, Liguria, 이탈리아, 16147
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Toscana
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Firenze, Toscana, 이탈리아, 50139
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Alberta
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Calgary, Alberta, 캐나다, T3B 6A8
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L1
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Toronto, Ontario, 캐나다, M5G 1X8
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Le Kremlin Bicêtre, 프랑스, 94275
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New South Wales
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Westmead, New South Wales, 호주, 2145
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Victoria
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Parkville, Victoria, 호주, 3052
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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
1년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
- Diagnosis of pJIA according to International League of Associations for Rheumatology classification
- Rheumatoid factor (RF)-positive pJIA
- RF-negative pJIA
- Extended oligoarticular JIA with a polyarticular course
- History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
- Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
- Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator
- Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the time of the screening visit
- Females who are pregnant, lactating, or intending to become pregnant during study conduct
- Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
- Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
- History of alcohol, drug, or chemical abuse within 6 months of screening
- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
- Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
- History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
- History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
- History of or current cancer or lymphoma
- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
- Active uveitis at screening
- Inadequate hematologic, renal or liver function
- Prior stem cell transplant at any time
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TCZ SC 162 mg Q3W
Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
다른 이름들:
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실험적: TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Minimum Serum Concentration (Cmin) of TCZ at Steady State
기간: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
기간: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
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Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Maximum Serum Concentration (Cmax) of TCZ at Steady State
기간: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Serum Interleukin-6 (IL-6) Levels
기간: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset.
It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in Soluble IL-6 Receptor Levels
기간: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in C-Reactive Protein (CRP) Levels
기간: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
기간: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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The ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline indicates improvement.
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Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
기간: Baseline up to Week 52
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Baseline up to Week 52
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
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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
2013년 7월 1일
기본 완료 (실제)
2016년 5월 1일
연구 완료 (실제)
2016년 5월 1일
연구 등록 날짜
최초 제출
2013년 6월 14일
QC 기준을 충족하는 최초 제출
2013년 7월 17일
처음 게시됨 (추정)
2013년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 6월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 16일
마지막으로 확인됨
2017년 5월 1일
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. .
청소년 특발성 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
Tocilizumab에 대한 임상 시험
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Hoffmann-La Roche완전한류마티스 관절염프랑스, 독일, 이탈리아, 스페인, 영국, 홍콩, 미국, 콜롬비아, 브라질, 캐나다, 뉴질랜드, 남아프리카, 필리핀 제도, 러시아 연방, 태국, 싱가포르, 불가리아, 멕시코, 호주, 리투아니아, 폴란드, 아르헨티나, 루마니아, 푸에르토 리코, 과테말라, 페루
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Shanghai Ninth People's Hospital Affiliated to...모병
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Assistance Publique - Hôpitaux de ParisMinistry of Health, France완전한