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

Systemic Juvenile Idiopathic Arthritis (SJIA) Clinical Trial

— ß-SPECIFIC 4  

Official title:

β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296424
• Other study ID #: CACZ885G2306
• Secondary ID: 2013-004867-29
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2014
• Est. completion date: September 25, 2017

Study information

• Verified date: June 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This two-part open-label study was to 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 was also to collect long term safety and tolerability data on SJIA patients treated with canakinumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 25, 2017
• Est. primary completion date: October 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Systemic Juvenile Idiopathic Arthritis (SJIA)

Intervention

Drug:
• ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Laeken
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Paulo	SP
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Colombia
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Paris cedex 15
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Giessen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Sankt Augustin	North Rhine-Westphalia
Germany	Novartis Investigative Site	Tübingen
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Kfar Saba
Israel	Novartis Investigative Site	Petach-Tikva
Israel	Novartis Investigative Site	Ramat Gan
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
Netherlands	Novartis Investigative Site	Utrecht
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Spain	Novartis Investigative Site	Esplugues de Llobregat	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Sweden	Novartis Investigative Site	Stockholm
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Izmir
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval.	The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration.; In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward.	baseline to 24 weeks
Secondary	Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1	AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)	During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks).
Secondary	Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2	AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)	During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks).