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Completed

NCT Number: NCT02296424

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

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.

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Key information

Conditions

Systemic Juvenile Idiopathic Arthritis (sJIA) Arthralgia Arthritis Arthritis, Juvenile Autoimmune Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Connective Tissue Diseases Graft vs Host Disease Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Musculoskeletal Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Rheumatic Diseases Rheumatoid Arthritis, Systemic Juvenile Signs and Symptoms Skin and Connective Tissue Diseases

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACZ885 150 mg (Canakinumab)

Drug

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

Other names: ACZ885 150 mg

Primary outcomes

  1. Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval.

    Time frame: baseline to 24 weeks

    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.

Secondary outcomes

  1. Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1

    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).

    AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)

  2. Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2

    Time frame: During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks).

    AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: ß-SPECIFIC 4

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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