EUCTR2008-008008-42-BE进行中（未招募）不适用
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
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.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 before any study related activity is performed.
- •2.The following patients are eligible to participate in the open label
- •extension study (CACZ885G2301E1):
- •Patients from study CACZ885G2305 or CACZ885G2301 who achieved
- •an adapted ACR pediatric 30 response 15 days after their initial dose of
- •canakinumab but clinically deteriorated AS DEFINED BY a minimum ACR
- •Pediatric 30 response not BEING maintained after Day 15 and
- •intervention is deemed necessary by the investigator.
- •Patients in study CACZ885G2301 who are not eligible to enter Part II
- •(withdrawal part) because they were not able to meet the corticosteroid
- •entry criteria of 0.5 mg/kg oral prednisone (or equivalent) or were not
- •able to taper their steroids by at least 0.3 mg/kg (please refer to
- •CACZ885G2301 protocol for detailed rules)
- •Responder patients in Part I or Part II who were maintaining their
- •minimum ACR pediatric 30 response or had not flared when
- •CACZ885G2301 was stopped.
- •CACZ885G2301 patients who were responders in Part I (achieved and
- •maintained a minimum adapted ACR pediatric 30) but experienced a
- •flare in Part II.
- •Treatment-naïve patients need to meet the following criteria:
- •- Confirmed diagnosis of Systemic Juvenile Idiopathic Arthritis as per
- •ILAR definition that must have occured at least 2 months prior to
- •enrollment with onset of disease < 16 years of age
- •- Male and female patients aged = 2 TO < 20 years of age
- •- Active disease at the time of enrollment defined as having 2 or more of
- •the following:documented spiking, intermittent fever (body temperature
- •>38°C) for at least 1 day during the screening period and within 1 week
- •before first canakinumab dose; at least 2 joints with active arthritis; Creactive
- •protein (CRP) > 30 mg/l (normal range < 10 MG/L); rash;
- •serositis; lymphadenopathy and hepatosplenomegaly
- •- Naïve to canakinumab
- •OTHER PROTOCOL-DEFINED INCLUSION CRITERIA MAY APPLY
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 205
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or nursing (lactating) female patients
- •2. Female patients having reached sexual maturity UNLESS they are:
- •female patients whose career, lifestyle, or sexual orientation precludes
- •intercourse with a male partner and/or
- •using an acceptable method of contraception with a failure rate (Pearl
- •Index (PI)) < 1.
- •Reliable contraception should be maintained throughout the study and
- •for 3 months after study drug discontinuation.
- •3. History hypersensitivity to study drug or to biologics.
- •4. With active or recurrent bacterial, fungal or viral infection at the time
- •of enrollment
- •5. Risk factors for tuberculosis (TB)
- •6. With underlying metabolic, renal, hepatic, infectious or
- •gastrointestinal conditions which in the opinion of the investigator
- •immunocompromises the patient and/ or places the patient at
- •unacceptable risk for participation in an immunodulatory therapy. In
- •particular, clinical evidence or history of multiple sclerosis or other
- •demyelinating diseases, or Felty's syndrome
- •7. With neutropenia (absolute neutrophil count <1500/mm3) at
- •8. With significant medical conditions, which in the opinion of the
- •Investigator will exclude the patient from the study (can be discussed on
- •a case by case basis with Novartis)
- •9. History of malignancy of any organ system (other than localized basal
- •cell carcinoma of the skin), treated or untreated, within the past 5 years,
- •regardless of whether there is evidence of local recurrence or
- •10. Live vaccinations within 3 months prior to the start of the study.
- •Killed or inactivated vaccines may be permitted according to the
- •investigator's discretion.
- •11. Donation or loss of blood (amount depending on age and weight, 10-
- •20% or more of volume, see Appendix 3 within 8 weeks prior to first
- •dosing, or longer if required by local regulation.
- •12. Familial and social conditions rendering regular medical assessment
- •not possible
- •13. History of drug or alcohol abuse within the 12 months prior to
- •No additional exclusions may be applied by the investigator, in order to
- •ensure that the study population will be representative of all eligible
- •OTHER PROTOCOL-DEFINED INCLUSION/EXCLUSION CRITERIA MAY
研究者
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