跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2007-000872-18-SK
EUCTR2007-000872-18-SK进行中（未招募）不适用

A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab

F. Hoffmann-La Roche Limited0 个研究点目标入组 108 人开始时间: 2008年4月9日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
108
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Age 2 up to and including 17 years at screening into trial;
  • •2. Systemic Juvenile Idiopathic Arthritis according to ILAR classification (2001);
  • •3. More than 6 months of persistent sJIA activity prior to screening including an
  • •inadequate response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.
  • •4. Presence of active disease as determined by the presence of :
  • •= 5 active joints, or
  • •= 2 active joints and fever >38°C for at least 5 out of any 14 consecutive days
  • •during screening and receiving prednisone or equivalent at a stable dose at no more than 0.5 mg/kg/day or 30 mg/day, whichever is less. During this same time
  • •period the corticosteroid dose continues unchanged.
  • •5. hsCRP > 4.3 mg/L or 0.43 mg/dl (1.5 x ULN (ULN= 0.28 mg/dl));
  • •6. Recovered from any symptomatic serositis for at least one month prior to the
  • •screening visit, and requiring dose of corticosteroids = than 30 mg/day at baseline
  • •7. Fertility:
  • •Female not of child-bearing potential, or
  • •Female of child-bearing potential practicing effective contraceptive measures,
  • •having a negative urine pregnancy test within three weeks prior to randomization;,
  • •Sterile male, or
  • •Non sterile male practicing effective contraceptive measures with female partner
  • •of child-bearing potential.
  • •[Females of childbearing potential must be using a reliable means of contraception
  • •(abstinence being a possible option) throughout the study and up to 12 weeks after the last infusion of study drug].
  • •8. Must meet one of the following:
  • •not receiving MTX, or discontinued MTX at least 4 weeks prior to baseline visit,
  • •taking MTX for at least 12 weeks immediately prior to the baseline visit and on a
  • •stable dose of =20 mg/m2 for at least 8 weeks prior to the baseline visit, together
  • •with either folic acid or folinic acid according to local standard of care.
  • •9. Never treated with biologics or, if previously treated with biologics, discontinued
  • •etanercept = 2 weeks, infliximab or adalimumab = 8 weeks, anakinra =1 week, or
  • •abatacept = 12 weeks prior to the baseline visit;
  • •10. Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable
  • •dose for a minimum of 2 weeks prior to the baseline visit at no more than 30 mg/day
  • •or 0.5 mg/kg/day whichever is less;
  • •11. Not taking NSAIDs, or taking no more than 1 type of NSAID at a stable dose for a
  • •minimum of 2 weeks prior to the baseline visit and is less than or equal to the
  • •maximum recommended daily dose;
  • •12. Written informed consent for study participation obtained from parents or legal
  • •guardian, with assent as appropriate by the patient, depending on the level of the
  • •patient’s understanding;
  • •13. Parental or guardian written agreement to comply with the requirements of the study protocol.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. Wheelchair or bedridden;
  • •2. Any other auto-immune, rheumatic disease or overlap syndrome other than sJIA;
  • •3. Not fully recovered from recent surgery or less than six weeks since surgery, at the
  • •time of screening visit; or planned surgery during the initial 12 weeks of the study;
  • •4. Lack of peripheral venous access;
  • •General Safety
  • •1. Pregnant, lactating, or intending to become pregnant during study conduct and up to
  • •12 weeks after the last administration of study drug;
  • •2. Any significant concurrent medical or surgical condition which would jeopardize the
  • •patient’s safety or ability to complete the trial;
  • •3. History of significant allergic or infusion reactions to prior biologic therapy;
  • •4. Inborn conditions characterized by a compromised immune system;
  • •5. Known HIV infection or other acquired forms of immune compromise;
  • •6. History of alcohol, drug or chemical abuse within 6 months of screening;
  • •7. Evidence of serious uncontrolled concomitant diseases including but not limited to
  • •the nervous system, renal, hepatic or endocrine;
  • •8. Asthma for which the patient has required the use of oral or parenteral corticosteroids
  • •for = 2 weeks within 6 months prior to the baseline visit;
  • •9. Any active acute, subacute, chronic or recurrent bacterial, viral or systemic fungal
  • •infection including but not limited to:
  • •a) acute or chronic renal / bladder infections,
  • •b) acute or chronic pulmonary infections;
  • •10. History of atypical tuberculosis;
  • •11. Active TB requiring treatment within 2 years prior to screening visit;
  • •12. Positive PPD at screen, unless treated with anti-tuberculosis therapy for at least 4 weeks prior to receiving study medication and chest radiograph is negative for active tuberculosis;
  • •13. Any major episode of infection requiring hospitalization or treatment during
  • •screening or treatment with IV antibiotics completing within 4 weeks of the screening
  • •visit or oral antibiotics completing within 2 weeks of the screening visit;
  • •14. History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein Bar virus within 2 months of the screening visit;
  • •15. Hepatitis B surface Ag or hepatitis C Ab positive;
  • •16. Chronic hepatitis – viral or autoimmune;
  • •17. Significant cardiac [e.g. congenital heart disease, valvular heart disease, constrictive pericarditis (unrelated to systemic JIA), myocarditis] or pulmonary disease, (e.g. asthma, cystic fibrosis);
  • •18. History or concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn’s disease, ulcerative colitis or other symptomatic lower gastrointestinal conditions, including ulcer and perforation;
  • •19. History of or current cancer or lymphoma;
  • •20. Uncontrolled diabetes mellitus defined as Hgb A1c > 8.8 mg/dL;
  • •21. History of macrophage activation syndrome within 3 months prior to the screening visit;
  • •Excluded Previous or Concomitant Therapy
  • •1. Participation in another interventional clinical trial within the past thirty days or five
  • •serum half-lives or the pharmacodynamic effect of the investigative medication,
  • •whichever is longer;
  • •2. Previous treatment with tocilizumab;
  • •3. Intra-articular, intramuscular, intravenous or long-acting (such as dexamethasone)
  • •corticosteroids within 4 weeks prior to the baseline visit;
  • •4. Treatment with DMARDs (other than MTX) or immunosuppressants, including but
  • •not limited to: hydroxychloroquine, chloroquine, gold, azathioprine, D-penicillamine,
  • •sulfasalazine, cyclosporine or thalidomide within 6 weeks p

研究者

发起方
F. Hoffmann-La Roche Limited

相似试验

进行中（未招募）
不适用
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumabSystemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis
EUCTR2007-000872-18-SEF. Hoffmann-La Roche Limited108
进行中（未招募）
不适用
The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.
EUCTR2007-000872-18-CZF. Hoffmann-La Roche Ltd.108
进行中（未招募）
1 期
The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.
EUCTR2007-000872-18-GBF. Hoffmann-La Roche Ltd.112
进行中（未招募）
不适用
The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.Systemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 14.0Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
EUCTR2007-000872-18-DEF. Hoffmann-La Roche Ltd.108
进行中（未招募）
1 期
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab.Systemic Juvenile Idiopathic Arthritis (sJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis
EUCTR2007-000872-18-NOF. Hoffmann-La Roche Limited108