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

March 14, 2012
February 26, 2014
December 2011
January 2014   (final data collection date for primary outcome measure)
long-term safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Incidence of SAEs and AEs of interest
Same as current
Complete list of historical versions of study NCT01557452 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA)
An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA) JIA

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis
Drug: Givinostat
oral suspension, 0,75 mg/Kg b.i.d. in fed conditions
Experimental: Givinostat
Intervention: Drug: Givinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01557452
DSC/11/2357/42
No
Italfarmaco
Italfarmaco
Parexel
Not Provided
Italfarmaco
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP