EUCTR2007-004367-22-FR进行中（未招募）不适用
An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Male and female patients at least 4 years of age at the time of the screening visit.
- •Patient’s informed consent for = 18 years of age before any assessment is
- •Parent or legal guardian’s written informed consent and child’s assent, if
- •appropriate, are required before any assessment is performed for patients
- •<18 years of age.
- •Patients with a diagnosis of FCAS, MWS, or MWS with overlapping symptoms of
- •NOMID (very severe MWS patients, including central nervous system (CNS)
- •symptoms, can be included only with prior agreement from Novartis). At study
- •entry, new patients should have symptoms requiring pharmacological intervention.
- •At the time of screening, patients can be either untreated or treated (i.e. under
- •ACZ885, anakinra, or any other investigational IL-1 blocking therapy). Prior
- •agreement between the Investigator and Novartis for study eligibility is required
- •for patients who do not have a molecular diagnosis of NALP3 mutations available
- •upon study entry.
- •For patients under anakinra therapy or any other investigational IL-1 blocking
- •therapy, these treatments should be discontinued prior to the baseline visit (see
- •Section 6.5.8 for specific time points for discontinuing treatments prior to the
- •baseline visit).
- •Patients from the A2102 study may enter this study upon signing informed
- •consent irrespective of whether they are in remission or flaring. However, dosing
- •at Visit 2 (Baseline Visit) can only occur if either 1) the patient is experiencing
- •disease flare or 2) at least two months have elapsed from their last injection even
- •in the absence of flare, whichever is earlier.
- •Patients who completed the D2304 study may enter this study upon signing
- •informed consent. A patient is defined as completing the study if he/she
- •completed the D2304 study up to and including Visit 15 (End of Study Visit).
- •Patients who discontinued from the A2102 or D2304 studies and for whom in the
- •Investigator’s judgment (with prior agreement from Novartis) treatment with
- •ACZ885 in this study is considered appropriate.
- •Body weight = 15 kg.
- •Able to communicate with the investigator and comply with the requirements of
- •the study (for children the parent can assist when necessary).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential unless they meet the following definition of postmenopausal state: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the acceptable methods of contraception detailed in the protocol are used.
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if
- •required by local regulation with the exception of trials with anakinra, other
- •investigational IL-1 blocking therapies, and/or ACZ885.
- •History of being immunocompromised, including a positive HIV at screening
- •(ELISA and Western blot) test result.
- •A positive HBsAg or Hepatitis C antibody test result.
- •Live vaccinations within 3 months prior to the start of the trial, during the trial, and
- •up to 3 months following the last dose.
- •History of drug or alcohol abuse within the 12 months prior to dosing.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing for
- •adults (For children the cut-off amount of donation or loss of blood should be
- •based on the Investigator's judgment & according to the local regulations. Please
- •also refer to Appendix 4 for the recommended sample volume per blood draw for
- •History of significant medical conditions, which in the Investigator’s opinion would
- •exclude the patient from participating in this trial (this can be discussed with
- •Novartis on a case by case basis in case of uncertainty).
- •History of recurrent and/or evidence of active bacterial, fungal, or viral infections.
- •Positive tuberculin skin test reaction (PPD 5 tuberculin units or as according to
- •local standard practice) (= 5 mm induration) at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to
- •national guidelines. Patients who have a positive PPD skin test with a
- •documentation of BCG vaccination, who are at low environmental risk for
- •tuberculosis (TB) infection or reactivation, and have a negative chest X-ray can be
- •included. A positive PPD test has been defined using the [MMWR 2000
- •guidance], summarized as criteria for tuberculin positivity by risk group:
- •equal or greater than 15 mm of induration for persons with no risk factors for
- •equal or greater than 10 mm of induration for persons with an increased
- •probability of recent infection or with other clinical conditions that increased
- •the risk for TB
- •equal or greater than 5 mm of induration for very high risk population (HIV),
- •contact TB cases, immunosuppression (organ transplantation, steroids
- •> 15 mg/day of prednisone for 1 month or more).
- •Precaution against tuberculosis should be handled according to the best medical
- •practice consistent to the local standards in each country with prior consultation
- •with Novartis. Patients requiring administration of antibiotics against latent
- •tuberculosis should complete their treatment and should be considered cured
- •prior to being re-considered for entry into this study.
- •Etanercept in the 4 weeks prior to the baseline visit (Day 1) and thereafter
- •Adalimumab in the 8 weeks prior to the baseline visit (Day 1) and thereafter
- •Infliximab in the 12 weeks prior to the baseline visit (Day 1) and thereafter
- •Rituximab in the 26 weeks prior to the baseline visit (Day 1) and thereafter
- •Any other investigational biologics in the 8 weeks prior to the baseline visit
- •(Day 1) and thereafter (with the exception of
研究者
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