- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00426218
Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Origgio, Italy
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
ACZ885
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety, tolerability and immunogenicity of subcutaneous (s.c.) ACZ885
|
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.
|
pharmacokinetics of ACZ885
|
To assess pharmacokinetics (PK) / pharmacodynamics (PD) relationships in order to derive a dose and dosing regimen
|
Secondary Outcome Measures
Outcome Measure |
---|
proportion of patients with inactive disease at each dose level.
|
To investigate the possibility of corticosteroid tapering.
|
biomarker and pharmacogenomic characterization of patients at baseline and to evaluate the treatment response to ACZ885.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CACZ885A2203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis, Juvenile Rheumatoid
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
National Eye Institute (NEI)CompletedUveitis | Arthritis, Juvenile RheumatoidUnited States
-
AmgenImmunex CorporationTerminatedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Bristol-Myers SquibbCompletedJuvenile Rheumatoid ArthritisUnited States, Portugal, Italy, Brazil, Germany, Peru, France, Spain, Mexico, Austria, Switzerland
Clinical Trials on ACZ885
-
Novartis PharmaceuticalsTerminatedAbdominal Aortic Aneurysm (AAA)Denmark, United States, Netherlands, Sweden, United Kingdom
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompletedTNF-receptor Associated Periodic Syndromes (TRAPS)United Kingdom, Ireland, Italy
-
NovartisCompleted
-
NovartisCompletedWet Age-Related Macular DegenerationUnited Kingdom, Switzerland
-
Novartis PharmaceuticalsWithdrawnDiabetes Mellitus | Diabetes Type 1Germany, United Kingdom, United States, Canada
-
Novartis PharmaceuticalsCompletedCytokine Release Syndrome (CRS) in Patients With COVID-19-induced PneumoniaSpain, United States, United Kingdom, Russian Federation, Italy, France
-
Novartis PharmaceuticalsCompletedSickle Cell AnemiaTurkey, United States, Germany, Canada, United Kingdom, Israel, South Africa
-
Novartis PharmaceuticalsNo longer availableCytokine Release Syndrome in COVID-19-induced Pneumonia
-
Novartis PharmaceuticalsCompletedDiabetes Mellitus, Type 2 | Atherosclerosis | Prediabetic StateGermany, Israel, United States, Canada, United Kingdom