Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00426218 |
Date of registration:
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23/01/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
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Scientific title:
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Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) |
Date of first enrolment:
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December 2006 |
Target sample size:
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26 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00426218 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Novartis |
Address:
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Telephone:
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Email:
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Affiliation:
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Investigative site |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female subjects aged 4 to 20 years
- Female subjects of child-bearing potential may participate if they have a negative
pregnancy test at screening and prior to dosing, and are willing to use, if adequate
for age, an effective method of contraception (e.g. birth control pills, abstinence,
double-barrier contraception, etc.) during the study (from the date of screening) and
for at least 3 months following the last dose.
- Patient meets the diagnostic criteria for SJIA, has at least 6 months disease
duration and has active disease at the time of enrollment defined as follows:
At least 2 joints with active arthritis (using ACR definition of active joint) Spiking,
intermittent fever (body temperature > 38°C only for several hours during the day) CRP >
50 mg/L (normal range < 10 mg/L).
- Patients who have not taken Anakinra, who have discontinued or failed anakinra
(according to physician's decision) or are willing to discontinue anakinra use under
close monitoring (run in phase) until relapse (reappearance of fever and/or CRP
increase).
- Willing to discontinue second line agent such as disease-modifying and
immunosuppressive drugs, not including methotrexate and corticosteroids.
- Body weight of at least 12 kg.
Exclusion Criteria:
-Use of: Etanercept in the four weeks prior to the Baseline visit Adalimumab in the eight
weeks prior to the Baseline visit Infliximab in the eight weeks prior to the Baseline
visit Any other investigational biologics in the eight weeks prior to the Baseline visit
Leflunomide in the four weeks prior to the Baseline visit. Documentation of a completion
of a full cholestyramine elimination procedure after most recent leflunomide use will be
required Thalidomide in the four weeks prior to the baseline visit Growth hormone in the
four weeks prior to the baseline visit Cyclosporine in the four weeks prior to the
Baseline visit Sulfasalazine or hydroxychloroquine in the eight weeks prior to the
Baseline visit i.v. immunoglobulin (i.v. Ig) in the eight weeks prior to the Baseline
visit 6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, in the 24 weeks
prior to the Baseline visit Wash-out period may be longer according to local requirements.
- History of recurrent bacterial, fungal or viral infection.
- Evidence of currently active bacterial, fungal or viral infection.
- Administration of live attenuated vaccine in the 3 months prior to the screening
visit .
- Uncontrolled severe systemic symptoms and/or biologic features of Macrophage
Activation Syndrome (hemorrhages, central nervous system dysfunction, hepatomegaly,
serum fibrinogen level < 2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet
count, increased aspartate transaminase, hyperferritinemia) (Ravelli, et al 2005).
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
4 Years
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Juvenile Rheumatoid
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Intervention(s)
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Drug: ACZ885
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Primary Outcome(s)
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To assess pharmacokinetics (PK) / pharmacodynamics (PD) relationships in order to derive a dose and dosing regimen
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pharmacokinetics of ACZ885
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Safety, tolerability and immunogenicity of subcutaneous (s.c.) ACZ885
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To assess the initial efficacy profile of s.c. ACZ885: % responder to treatment and time to relapse and control the systemic manifestations of SJIA such as fever.
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Secondary Outcome(s)
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proportion of patients with inactive disease at each dose level.
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To investigate the possibility of corticosteroid tapering.
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biomarker and pharmacogenomic characterization of patients at baseline and to evaluate the treatment response to ACZ885.
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Secondary ID(s)
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CACZ885A2203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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