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An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Italfarmaco
ClinicalTrials.gov Identifier:
NCT01557452
First received: March 14, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.


Condition Intervention
Juvenile Idiopathic Arthritis
 Drug: Givinostat

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA) JIA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Italfarmaco:

Primary Outcome Measures:
  • long-term safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Incidence of SAEs and AEs of interest


Secondary Outcome Measures:
  • ACR pediatric 30 level of response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To maintan the Pediatric ACR 30 level(ACR: American COllege of Rheumatology) reached during the participation to the previous study (DSC/08/2357/36)

  • ACR pediatric 50 and 70 levels of response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To improve the Pediatric ACR levels to PedACR50 or PedACR70


Estimated Enrollment: 3
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Givinostat Drug: Givinostat
oral suspension, 0,75 mg/Kg b.i.d. in fed conditions

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36

Exclusion Criteria:

  • patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
  • active bacterial or mycotic infection requiring antimicrobial treatment
  • episode of macrophage activation syndrome over the last 6 months
  • baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
  • clinically significant cardiovascular disease
  • clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
  • psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
  • inherited metabolic diseases
  • presence of malignancy
  • pregnancy or lactation
  • positive blood test for HIV
  • active EBV infection, active B and/or C hepatitis
  • platelet count <100x10(9)/L
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557452

Locations
Czech Republic
1st Faculty of Medicine and General Faculty Hospital
Praha, Czech Republic, 12109
Sponsors and Collaborators
Italfarmaco
Parexel
  More Information

No publications provided

Responsible Party: Italfarmaco
ClinicalTrials.gov Identifier: NCT01557452     History of Changes
Other Study ID Numbers: DSC/11/2357/42
Study First Received: March 14, 2012
Last Updated: November 20, 2012
Health Authority: Czech Republic: Eticka komise Vseobecne fakultni nemocnice v Praze

Keywords provided by Italfarmaco:
JIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013