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)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00570661
• Date of registration: 10/12/2007
• Prospective Registration: No
• Primary sponsor: Italfarmaco
• Public 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) SOJIA
• Scientific 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)
• Date of first enrolment: August 2006
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00570661
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Former Serbia and Montenegro, Serbia

Contacts

• Name: Tiziano TO Oldoni, MD
• Affiliation: Italfarmaco

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 25 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Active Systemic

Onset Juvenile Idiopathic Arthritis

Intervention(s)

Drug: ITF2357

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

DSC/05/2357/19

DSC/05/2357/19 2006-000089-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors