EUCTR2009-011593-15-ES进行中（未招募）1 期
Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
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. Documented evidence of polyarticular-course juvenile idiopathic arthritis (pcJIA):
- •?Rheumatoid Factor Positive or Rheumatoid Factor Negative JIA polyarthritis subset (pJIA) for at least 6 months -or -
- •?extended oligoarticular JIA (eoJIA) with active polyarticular course for at least 6 months
- •prior to study entry according to ILAR Criteria
- •2. Polyarticular-course JIA requiring presence of active disease with at least five joints with active arthritis (joints that are swollen or if no swelling is present limitation of movement accompanied by pain tenderness or both) at both screening and baseline (with a least three of the active joints having limitation of motion).
- •3. Age 2 years up to and including age 17 years at the time of enrollment
- •4. Must meet one of the following:
- •?Have had an inadequate response to MTX or
- •?Inability to tolerate MTX
- •5. Must meet one of the following:
- •?not receiving MTX for at least 4 weeks prior to baseline visit, -or-
- •?taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of ?10 to ?20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid.
- •6. Must meet one of the following:
- •?Not currently receiving oral corticosteroids ?or-
- •?taking oral corticosteroids at a stable dose for a minimum of 4 weeks prior to the baseline visit at no more than 10 mg/day or 0.2 mg/kg/day whichever is less;
- •8. Must meet one of the following:
- •?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;
- •9. Must meet one of the following
- •?Never treated with biologics ?or-,
- •?If previously treated must have discontinued anakinra ? 1 week prior to baseline, etanercept ? 2 weeks prior to baseline, rilonacept ? 5 weeks prior to baseline, infliximab or adalimumab ? 8 weeks prior to baseline, abatacept ? 12 weeks prior to baseline or canakinumab ? 20 weeks prior to baseline.
- •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 bound or bedridden or has little or no ability for self-care;
- •2. Any other auto-immune, rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets; Rheumatoid Factor Positive polyarticular JIA, Rheumatoid Factor Negative polyarticular JIA, and extended oligoarticular JIA. The excluded illnesses include but are not limited to systemic juvenile idiopathic arthritis, Lyme disease, enthesitis-related arthritis; psoriatic arthritis, Reiter?s syndrome, systemic lupus erythematosus, infectious or reactive arthritis or parvovirus infections
- •3. History of significant allergic or infusion reactions to prior biologic therapy;
- •4. Evidence of serious uncontrolled concomitant diseases including but not limited to the cardiovascular, pulmonary, nervous, renal, hepatic or endocrine system
- •5. Any active acute, subacute, chronic or recurrent bacterial, mycobacterial, viral or systemic fungal infection or opportunistic infection
- •6. Active TB requiring treatment within 2 years prior to screening visit or currently active TB;
- •7. Positive PPD at screen unless chest radiograph is negative for active tuberculosis at screen and patient treated with anti-tuberculosis therapy for at least 4 weeks prior to receiving study medication
- •8. 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;
- •9. Known active current or history of recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infections, (e.g. bronchiectasis, ), an open or draining or infected skin wound, sinusitis, recurrent urinary tract infection ( e.g. recurrent pyelonephritis )
- •10. 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;
- •11. Active uveitis (absence of uveitis must be documented by a slit lamp ophthalmology examination within 12 weeks prior to baseline).
- •12. Previous treatment with tocilizumab;
- •13. Serum creatinine >1.5 ULN (upper limit of normal for age and sex);
- •14. AST or ALT > 1.5 ULN (upper limit of normal for age and sex);
- •15. Total bilirubin > 1.3 mg/dL (> 23 umol/L);
- •16. Platelet count < 150 x 10e3/µL (< 150,000/mm3);
- •17. Hemoglobin < 9.0 g/dL (< 3.7 mmol/L);
- •18. WBC count < 5,000/mm3 (< 5.0 x 10e9/L);
- •19. Neutrophil count < 2,500/ mm3 (< 2.5 x 10e9/L);
研究者
相似试验
进行中（未招募）
1 期
Ensayo clínico fase III, de 24 semanas de duración y 28 semanas de seguimiento, multicéntrico, aleatorizado, doble ciego, estratificado por edad, controlado con placebo para evaluar la eficacia y seguridad de dapagliflozina 10 mg una vez al día, en pacientes diabéticos tipo 2, con historia de enfermedad cardiovascular e hipertensión arterial, y que presenten mal control glucémico con su tratamiento habitual.A 24-week, multicentre, randomised, double-blind, age-stratified, placebo controlled phase III study with a 28-week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with type 2 diabetes, cardiovascular disease and hypertension, who exhibit inadequate glycaemic control on usual care.EUCTR2009-016791-71-ESAstraZeneca AB1,175
进行中（未招募）
1 期
A 24-week off drug extension study assessing the durability of effect of bimagrumab in older adults with sarcopenia previously participating in the 6-month core studyEUCTR2015-000471-27-DKovartis Pharma Services AG200
进行中（未招募）
不适用
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic RhinitisPerennial Allergic RhinitisEUCTR2014-004922-16-Outside-EU/EEACorporation Schering-Plough K.K.80
已完成
不适用
A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guidelineJPRN-UMIN000035079CureApp, Inc.14
已完成
2 期
Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome treated with oral Eubacterium halliiMetabolic syndrome10018424NL-OMON44478Academisch Medisch Centrum27