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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003341-18 | EudraCT Number |
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Previous study DSC/08/2357/36 did not show efficacy for Givinostat in JIA. Sponsor decision to stop development of Givinostat in polyarticular course Juvenile Idiopathic Arthritis wasn't related to any tolerability concerns.
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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);
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Givinostat | Experimental | Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Givinostat | Drug | ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Maintained PedACR30 Response | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavla Dolezalova, MD | General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Faculty of Medicine and General Faculty Hospital | Prague | 12109 | Czechia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Givinostat | Givinostat: oral suspension, 0,75 mg/Kg b.i.d. in fed conditions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Givinostat | Givinostat: oral suspension, 0,75 mg/Kg b.i.d. in fed conditions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest | 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 | Posted | Number | participants | Through end of treatment, up to 108 weeks. |
|
|
Through end of treatment, up to 108 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Givinostat | Givinostat: oral suspension, 0,75 mg/kg b.i.d. in fed conditions | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 16 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bettica, MD | Italfarmaco SpA | +39 02 64431 | p.bettica@italfarmaco.com |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C575255 | givinostat |
| C502418 | givinostat hydrochloride |
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| At weeks 48, 60 and 108 |
| Number of Patients Who Reached PedACR70 Response | 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Number of Patients Who Maintained PedACR30 Response | 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) | Posted | Number | participants | At weeks 48, 60 and 108 |
|
|
|
| Secondary | Number of Patients Who Reached PedACR70 Response | 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) | Posted | Number | participants | At weeks 48, 60 and 108 |
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|
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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