- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557452
Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis
An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA)
Primary Objective of the study:
the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Praha, Czechia, 12109
- 1st Faculty of Medicine and General Faculty Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Givinostat
Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014
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ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest
Time Frame: Through end of treatment, up to 108 weeks.
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During the entire study period it was reported only one adverse event considered not drug related by the investigator (Mild flu at week 107 of study treatment). No action was taken and the patient recovered spontaneously |
Through end of treatment, up to 108 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Maintained PedACR30 Response
Time Frame: At weeks 48, 60 and 108
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This is an open-label treatment extension of the 2010-019094-15 study, an antecedent dose-ranging trial of Givinostat ready-to-use oral suspension formulation. Eligible patients were those who had completed the previous study achieving a clinical benefit, i.e. patients achieving at least an ACR Paediatric 30 (PedACR30). PedACR30 is defined as at least a 30% improvement from baseline in any three of the following six variables in juvenile idiopathic arthritis (JIA) patients, with no more than one variable worsening by more than 30%:
(ACR stands for American College of Rheumatology) |
At weeks 48, 60 and 108
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Number of Patients Who Reached PedACR70 Response
Time Frame: At weeks 48, 60 and 108
|
This is an open-label treatment extension of the 2010-019094-15 study, an antecedent dose-ranging trial of Givinostat ready-to-use oral suspension formulation. Eligible patients were those who had completed the previous study achieving a clinical benefit, i.e. patients achieving at least an ACR Paediatric 30 (PedACR30). PedACR70 is defined as at least a 70% improvement from baseline in any three of the following six variables in juvenile idiopathic arthritis (JIA) patients, with no more than one variable worsening by more than 30%:
(ACR stands for American College of Rheumatology) |
At weeks 48, 60 and 108
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pavla Dolezalova, MD, General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSC/11/2357/42
- 2011-003341-18 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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