NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142534

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHereditary Periodic Fevers
Date of first enrollment01/7/2014
Target sample size180
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : ACZ885 INN of the intervention : canakinumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo Dosage And administration of the control intervention : subcutaneous injection

Outcome(s)

Primary OutcomeProportion of participants with resolution of initial flare at time of the randomization and absence of new flares [ Time Frame: 16 weeks ] To demonstrate significant reduction of disease activity with canakinumab versus placebo
Secondary OutcomePercentage of participants who achieve Physician's global assessment < 2 [ Time Frame: 16 weeks ] Assessment of Physician's global assessment Percentage of participantswith the serologic remission [ Time Frame: 16 weeks ] Normalization of C-reactive protein, Serum Amyloid A

Key inclusion & exclusion criteria

Age minimum2
Age maximum
GenderBOTH
Include criteria*Patient's written informed consent (or parent's written informed consent in case of pediatric patient) at screening *Male and female patients at least 2 years of age at the time of the screening visit *Confirmed diagnosis and active flare at randomization *CRP >10mg/L at randomization
Exclude criteria*Use of the following therapies (within varying protocol defined timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, any other investigational biologics *History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in - situ cervical cancer), treated or untreated *Significant medical diseases, including but not limited to the following: a. History of organ transplantation b. Elevated liver enzymes >=2x ULN c. Increase in total bilirubin d. Serious hepatic disorder (Child-Pugh scores B or C) e. Chronic Kidney Disease f. Thyroid disease g. Diagnosis of active peptic ulcer disease h. Coagulopathy i. Significant CNS effects including vertigo and dizziness *Any conditions or significant medical problems which immunecompromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy *Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose Other protocol defined inclusion/exclusion may apply

Related Information

Contact

public contact
Name Novartis Pharma K. K. Novartis Direct
Address 0120-003-293
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scientific contact
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