EUCTR2007-004367-22-BE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 thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms 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
- •1. Male and female patients at least 4 years of age at the time of the screening visit.
- •2. Patient’s informed consent for = 18 years of age before any assessment is
- •3. 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.
- •4. Patients with a diagnosis of FCAS, MWS, or NOMID. At study
- •entry, new ACZ885 NAIVE 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 (EITHER TESTING NOT PERFORMED, OR TESTING PERFORMED BUT NEGATIVE) upon study entry. FOR THOSE PATIENTS WHO HAVE NOT BEEN MOLECULLARLY TESTED FOR NALP3 MUTATIONS, MOLECULAR TESTING SHOULD BE PERFORMED DURING THE COURSE OF THE STUDY.
- •5. 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).
- •6. 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.
- •7. 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).
- •8. PATIENTS WHO COMPLETED THE D2201 STUDY MAY ENTER THIS STUDY UPON SIGNING INFORMED CONSENT. A PATIENT IS DEFINED AS COMPLETING THE STUDY IF HE/SHE COMPLETED THE D2201 STUDY UP TO AND INCLUDING THE END OF STUDY VISIT
- •9. Patients who discontinued from the A2102, D2201 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.
- •10. 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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