Juvenile Idiopathic ArthritisNCT01557452
Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis
A study testing Givinostat in people with Juvenile Idiopathic Arthritis, run by Italfarmaco at 1 site in Czechia.
Trial summary
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); Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Givinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Dec 2011to 27 Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
1st Faculty of Medicine and General Faculty Hospital
Prague, 12109
About this study
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)
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);
Read the detailed description
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Givinostat
- Keywords
- JIA
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GivinostatDrug
Also called ITF2357
ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients
| Study group | Role | What they receive |
|---|---|---|
| Givinostat | Experimental | Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 Receives: Drug: Givinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through end of treatment, up to 108 weeks.
Secondary outcomes (2)
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%:
- physician's global assessment of disease activity;
- parent/guardian's or patient's global assessment of overall wellbeing;
- functional ability;
- number of joints with active arthritis;
- number of joints with limited range of motion;
- ESR. (ACR stands for American College of Rheumatology)
Measured: 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%:
- physician's global assessment of disease activity;
- parent/guardian's or patient's global assessment of overall wellbeing;
- functional ability;
- number of joints with active arthritis;
- number of joints with limited range of motion;
- ESR. (ACR stands for American College of Rheumatology)
Measured: At weeks 48, 60 and 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study start28 Dec 2011
- Primary completion27 Jan 2014
- Study completion27 Jan 2014
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Pavla Dolezalova, MD, Principal investigator, General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557452
- Sponsor's protocol ID
- DSC/11/2357/42
- Other IDs
- 2011-003341-18
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2012
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01557452
- Acronym / sponsor ID
- DSC/11/2357/42
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 28 Dec 2011 (actual)
- Primary completion
- 27 Jan 2014 (actual)
- Study completion
- 27 Jan 2014 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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);
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Givinostat | Experimental | Drug: GivinostatPatient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GivinostatAlso: ITF2357ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients | Drug | Givinostat |
Primary outcome
Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest
Time frame: Through end of treatment, up to 108 weeks.
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
2 secondary outcomes
Number of Patients Who Maintained PedACR30 Response
Time frame: At weeks 48, 60 and 108
Number of Patients Who Reached PedACR70 Response
Time frame: At weeks 48, 60 and 108
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavla Dolezalova, MD principal investigator
General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Givinostat in people with Juvenile Idiopathic Arthritis, run by Italfarmaco at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest (time frame: Through end of treatment, up to 108 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.