Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Italfarmaco
ClinicalTrials.gov Identifier:
NCT00570661
First received: December 10, 2007
Last updated: May 23, 2013
Last verified: January 2012
  Purpose

The present study has been designed in order to evaluate safety and tolerability of ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents, and to have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA.

ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults, which so far has been proven to be free of any relevant safety concerns both in healthy volunteers and in patients.


Condition Intervention Phase
Active Systemic
Onset Juvenile Idiopathic Arthritis
Drug: ITF2357
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)

Resource links provided by NLM:


Further study details as provided by Italfarmaco:

Primary Outcome Measures:
  • To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the possibility of steroid dose during ITF2357 treatment; To assess the effect of ITF2357 on circulating cytokines; To assess pk of ITF2357 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITF2357 Drug: ITF2357
ITF2357 will be supplied as hard gelatine capsule for oral administration at the dose strengths of 7.5, 10, 12.5, 15, 20 and 50 mg, identifiable by different colours. The dose of 1.5 mg/kg/day will be achieved by administration, at 12-hour interval, of an appropriate number of capsules of definite strength(s) as specified here below

  Eligibility

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established diagnosis of Systemic SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
  2. Active disease for at least one month prior to enrolment as defined by the following criteria:

    • Presence of arthritis plus at least one of the following:

      • Fever, defined as a body temperature >= 37,5 C degree at least once a day during at least five consecutive days or presence of typical SOJIA intermittent temperature chart
      • Rash, defined by presence of typical SOJIA salmon pink rash on the trunk and elsewhere during the febrile episodes
      • Serositis (pericarditis, pleuritis, peritonitis) confirmed by ultrasound and/or X-ray exploration or by presence of typical ECG findings in the case of pericarditis
      • Lymphadenopathy, defined by lymph nodes enlargement to 1,5 cm or more localized anywhere within the body, and/or hepatomegaly and/or splenomegaly, confirmed by ultrasound evaluation and established after comparison to age standards for organ size
      • ESR >= 20 mm/h (first hour) and/or CRP >= 10 mg/L. in the absence of arthritis, two definite or one definite and one probable diagnostic criteria plus ESR >=20 mm/h (first hour) and/or CRP >=10 mg/L
  3. Age at enrolment between 2 and 25 years
  4. Age at first SOJIA diagnosis < 16 years
  5. Previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to >= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
  6. In case of concomitant methotrexate treatment, it has to be on stable dose >= 10mg/m2 weekly for al least 4 weeks before pt enrollment
  7. Previous treatment with biologics, if any, during at least three months without satisfactory effect or with drug intolerability, discontinued for at least the period specified below before patient's enrolment:

    • Two months for etanercept
    • Six months for infliximab
  8. Other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half lives
  9. Concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient's enrolment
  10. Female of childbearing potential, using safe contraceptive measures
  11. Signed written informed consent before starting any study procedure

Exclusion Criteria:

  1. Ongoing clinical relevant viral infection (eg.: Herpes Zoster, Ebstein barr, CMV, Systemic fungal infections or history of recurrent serious bacterial infection)
  2. History of macrophage activation syndrome
  3. Clinically significant illness i.e. any condition (including laboratory abnormalities) 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
  4. Psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
  5. Congenital heart and/or central nervous system disorders
  6. Inherited metabolic diseases
  7. Positive serological testing for anti HCV, anti HIV and HBsAg (to be performed at screening)
  8. Pregnant or lactating women
  9. Presence of malignancy
  10. Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
  11. QTc interval > 450 msec at screening evaluation
  12. Serum magnesium and potassium below the LLN at screening
  13. Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570661

Locations
Serbia
Inst. of Rheumatology Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
Italfarmaco
Investigators
Study Director: Tiziano TO Oldoni, MD Italfarmaco
  More Information

No publications provided by Italfarmaco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Italfarmaco
ClinicalTrials.gov Identifier: NCT00570661     History of Changes
Other Study ID Numbers: DSC/05/2357/19, DSC/05/2357/19 2006-000089-35
Study First Received: December 10, 2007
Last Updated: May 23, 2013
Health Authority: Italy: Ministry of Health
Serbia: medicines and medical device agency of Serbia
Romania: ministry of public health national medicines agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Givinostat hydrochloride
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014