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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

December 10, 2007
May 23, 2013
August 2006
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00570661 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Active Systemic
  • Onset Juvenile Idiopathic Arthritis
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
Experimental: ITF2357
Intervention: Drug: ITF2357

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
August 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
Serbia
 
NCT00570661
DSC/05/2357/19, DSC/05/2357/19 2006-000089-35
No
Italfarmaco
Italfarmaco
Not Provided
Study Director: Tiziano TO Oldoni, MD Italfarmaco
Italfarmaco
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP