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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557452
Recruitment Status : Terminated (Previous study DSC/08/2357/36 did not show efficacy for Givinostat in JIA. Decision wasn't related to any tolerability concerns)
First Posted : March 19, 2012
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Givinostat Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Givinostat Drug: Givinostat
oral suspension, 0,75 mg/Kg b.i.d. in fed conditions

Primary Outcome Measures :
  1. long-term safety [ Time Frame: 1 year ]
    Incidence of SAEs and AEs of interest

Secondary Outcome Measures :
  1. 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)

  2. ACR pediatric 50 and 70 levels of response [ Time Frame: 3 months ]
    To improve the Pediatric ACR levels to PedACR50 or PedACR70

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557452

Czech Republic
1st Faculty of Medicine and General Faculty Hospital
Praha, Czech Republic, 12109
Sponsors and Collaborators

Responsible Party: Italfarmaco Identifier: NCT01557452     History of Changes
Other Study ID Numbers: DSC/11/2357/42
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Italfarmaco:

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