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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 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 ]
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 ]
    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 ]
    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
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
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT01557452
DSC/11/2357/42
No
Not Provided
Not Provided
Not Provided
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