Suspended

β-SPECIFIC 4PaAn Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

What is being tested

Canakinumab

+ Canakinumab

Drug

Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 2 to 20 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Last updated: October 15, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

This two-part open-label, multi-arm, non-comparative study will collect long-term safety, efficacy and tolerability data from patients who were responsive to canakinumab from study CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort 2). In addition, the effect of inactivated vaccines in an SJIA patient population will be assessed for the development of adequate (protective) antibody levels following immunization according to respective local vaccination guidelines. Study Part I: All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless discontinuation occurs, or until they qualify for Part II of the study. Study Part II: Patients who are eligible will be randomized to receive canakinumab at a reduced dose or prolonged dose interval (see requirements for dose reduction/dose interval prolongation below). Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will be part of the treatment arm canakinumab dose reduction if they are eligible.

NCT01676948

Principal SponsorNovartis Pharmaceuticals

Last updated: October 15, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, Juvenile

Criteria

6 inclusion criteria required to participate

All patients currently enrolled in study CACZ885G2301E1, including patients who discontinued canakinumab therapy for inactive disease in CACZ885G2301E1 as per physician discretion and who are now currently in a flare and require canakinumab therapy again

Active systemic disease at the time of baseline visit defined as having 2 or more of the following: * Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose, * At least 2 joints with active arthritis (using ACR definition of active joint), * C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L), * Rash, * Serositis, * Lymphadenopathy, * Hepatosplenomegaly

Confirmed diagnosis of SJIA as per ILAR definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age: Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: * Evanescent non-fixed erythematous rash, * Generalized lymph node enlargement, * Hepatomegaly and/ or splenomegaly, * Serositis

Male and female patients aged >= 2 to < 20 years at the time of the screening visit

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11 exclusion criteria prevent from participating

Active or recurrent bacterial, fungal or viral infection at the time of enrollment

History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases

Live vaccinations within 3 months prior to the start of the study

Underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/ or places the patient at unacceptable risk for participation in an immunomodulatory therapy

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)

Group II

Experimental

4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)

Group III

Experimental

2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)

Group IV

Experimental

4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)

Group 5

Experimental

Group 6

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers