ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab (ß-SPECIFIC 4)

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ClinicalTrials.gov Identifier: NCT02296424

Recruitment Status : Completed

First Posted : November 20, 2014

Last Update Posted : February 23, 2018

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Condition or disease	Intervention/treatment	Phase
Systemic Juvenile Idiopathic Arthritis (SJIA)	Drug: ACZ885 150 mg (Canakinumab)	Phase 3

Detailed Description:

This two-part open-label study will assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The study will also collect long term safety and tolerability data on SJIA patients treated with canakinumab.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	182 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Actual Study Start Date :	November 17, 2014
Actual Primary Completion Date :	September 25, 2017
Actual Study Completion Date :	September 25, 2017

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Juvenile idiopathic arthritis

MedlinePlus related topics: Arthritis Juvenile Arthritis

Drug Information available for: Canakinumab

Genetic and Rare Diseases Information Center resources: Systemic Onset Juvenile Idiopathic Arthritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Canakinumab Dose Reduction All patients will receive canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study will be randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab will be administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continues to maintain inactive disease for 24 additional weeks, canakinumab will be administered at 1mg/kg every 4 weeks. If the patient continues to maintain inactive disease for another 24 additional weeks, canakinumab treatment will be discontinued.	Drug: ACZ885 150 mg (Canakinumab) Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial. Other Name: ACZ885 150 mg
Experimental: Canakinumab Dose Interval Prolongation All patients will receive canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study will be randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval will be prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continues to be stable with inactive disease for 24 additional weeks, canakinumab dose interval is prolonged to a regimen of 4mg/kg every 12 weeks. If the patient is clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment will be discontinued.	Drug: ACZ885 150 mg (Canakinumab) Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial. Other Name: ACZ885 150 mg

Arm

Intervention/treatment

Experimental: Canakinumab Dose Reduction

All patients will receive canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study will be randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab will be administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continues to maintain inactive disease for 24 additional weeks, canakinumab will be administered at 1mg/kg every 4 weeks. If the patient continues to maintain inactive disease for another 24 additional weeks, canakinumab treatment will be discontinued.

Drug: ACZ885 150 mg (Canakinumab)

Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Other Name: ACZ885 150 mg

Experimental: Canakinumab Dose Interval Prolongation

All patients will receive canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study will be randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval will be prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continues to be stable with inactive disease for 24 additional weeks, canakinumab dose interval is prolonged to a regimen of 4mg/kg every 12 weeks. If the patient is clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment will be discontinued.

Drug: ACZ885 150 mg (Canakinumab)

Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Other Name: ACZ885 150 mg

Outcome Measures

Primary Outcome Measures :

Proportion of patients in clinical remission on canakinumab who are able to remain at an initial reduced canakinumab dose or prolonged canakinumab dose interval. [ Time Frame: During study part II, defined as completion of 24-weeks of randomized treatment. ]
To evaluate if patients in clinical remission who have successfully discontinued any concomitant corticosteroid and/or methotrexate can maintain inactive disease for 24 weeks (clinical remission) at a reduced canakinumab dose of 2mg/kg (150mg max) every 4 weeks or 4mg/kg (300mg max) every 8 weeks.

Secondary Outcome Measures :

Number and percentage of patients with adverse events as a measure of long-term safety and tolerability of canakinumab (Parts I and II). [ Time Frame: During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). ]
To assess the long-term safety and tolerability of canakinumab by overall frequency of adverse events.

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cohort 1:

• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1

Cohort 2:

Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age.
Active SJIA defined as having 2 or more of the following:
Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day within 1 week before first canakinumab dose;
At least 2 joints with active arthritis
C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
Rash due to SJIA
Serositis
Lymphadenopathy
Hepatosplenomegaly
Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative).

Exclusion Criteria:

With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
With 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.
With neutropenia (absolute neutrophil count < 1500/mm3) at screening.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296424

Show 50 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02296424 History of Changes
Other Study ID Numbers:	CACZ885G2306 2013-004867-29 ( EudraCT Number )
First Posted:	November 20, 2014 Key Record Dates
Last Update Posted:	February 23, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Juvenile Rheumatoid arthritis (JRA) chronic systemic inflammatory disorder painful joints inflammation of the synovial membrane	auto-immune rheumatoid disease reactive rheumatoid arthritis Systemic Juvenile Rheumatoid arthritis (SJRA)

Additional relevant MeSH terms:


Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases	Autoimmune Diseases Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs

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