An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. (β-SPECIFIC 3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Collaborators:
Pediatric Rheumatology International Trials Organization
Pediatric Rheumatology Collaborative Study Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00891046
First received: April 29, 2009
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.


Condition Intervention Phase
Systemic Juvenile Idiopathic Arthritis
Drug: Canakinumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assess the long-term safety, tolerability and immunogenicity of canakinumab. [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: Yes ]
  • Maintenance of at least an adapted ACR pediatric 30. [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: No ]
  • Primary Outcome Measure #2: Measure: Assess efficacy of canakinumab treatment based on adapted ACR pediatric 30 criteria in patients who report previous anakinra, tocilizumab or other biologic treatment [ Time Frame: Day 1 to 728 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients that were able to taper steroid as per protocol. [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: No ]
  • The number of patients who reached steroid free regimen. [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: No ]
  • The number of patients who were able to reduce the canakinumab dose to 2 mg/kg/4 week [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: No ]
  • The percentage of patients who will meet the definition of inactive disease on medication and possible clinical remission on medication [ Time Frame: Days 1 to 728 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab
Canakinumab
Drug: Canakinumab
Canakinumab

  Eligibility

Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in Part II.
  • Treatment-naïve patients need to meet the following criteria:

    • Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age
    • Male and female patients aged ≥ 2 to < 20 years of age
    • Active disease at the time of enrollment 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
      • AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
    • Naïve to canakinumab

Other protocol-defined inclusion criteria may apply

Exclusion criteria:

  • History of allergy or hypersensitivity to study drug
  • With active or recurrent bacterial, fungal or viral infections at time of enrollment

Other protocol inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891046

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 118 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Pediatric Rheumatology International Trials Organization
Pediatric Rheumatology Collaborative Study Group
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00891046     History of Changes
Other Study ID Numbers: CACZ885G2301E1, EudraCT: 2008-008008-42
Study First Received: April 29, 2009
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Lægemiddelstyrelsen
Greece: National Organization for Medicines
Russia: Federal Service on Surveillance in Healthcare and Social Development

Keywords provided by Novartis:
Flare
arthritis
IL-1beta antagonist
systemic juvenile idiopathic arthritis
CHAQ
steroids
ACR pediatric response
Systemic juvenile idiopathic arthritis with active flare

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014