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

This study has been terminated.
(Previous study DSC/08/2357/36 did not show efficacy for Givinostat in JIA. Decision wasn't related to any tolerability concerns)
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Italfarmaco
ClinicalTrials.gov Identifier:
NCT01557452
First received: March 14, 2012
Last updated: February 26, 2014
Last verified: February 2014
  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:


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


Enrollment: 1
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
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: 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: February 26, 2014
Health Authority: Czech Republic: Eticka komise Vseobecne fakultni nemocnice v Praze

Keywords provided by Italfarmaco:
JIA

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

ClinicalTrials.gov processed this record on October 19, 2014