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临床试验/NCT00570661
NCT00570661已完成2 期

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)

Italfarmaco5 个研究点 分布在 2 个国家目标入组 17 人开始时间: 2006年9月12日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
17
试验地点
5
主要终点
Number of Patients Completing Week 12 of Treatment
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study has the following objectives:

Primary objective:

  • 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.

Secondary objectives:

  • to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA
  • to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment
  • to assess the effect of ITF2357 on levels of circulating cytokines
  • to assess the pharmacokinetic properties of ITF2357

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Not applicable. The study was open label.

入排标准

年龄范围
2 Years 至 25 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.
  • •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
  • •Age at enrolment between 2 and 25 years
  • •Age at first SOJIA diagnosis < 16 years
  • •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
  • •In case of concomitant methotrexate treatment, it has to be on stable dose >= 10mg/m2 weekly for al least 4 weeks before pt enrollment
  • •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
  • •Other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half lives
  • •Concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient's enrolment
  • •Female of childbearing potential, using safe contraceptive measures
  • •Signed written informed consent before starting any study procedure

排除标准

  • •Ongoing clinical relevant viral infection (eg.: Herpes Zoster, Ebstein barr, CMV, Systemic fungal infections or history of recurrent serious bacterial infection)
  • •History of macrophage activation syndrome
  • •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
  • •Psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
  • •Congenital heart and/or central nervous system disorders
  • •Inherited metabolic diseases
  • •Positive serological testing for anti HCV, anti HIV and HBsAg (to be performed at screening)
  • •Pregnant or lactating women
  • •Presence of malignancy
  • •Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
  • •QTc interval > 450 msec at screening evaluation
  • •Serum magnesium and potassium below the LLN at screening
  • •Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes

研究组 & 干预措施

ITF2357

Experimental

ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).

Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity

干预措施: ITF2357 (Drug)

结局指标

主要结局

Number of Patients Completing Week 12 of Treatment

时间窗: At week 12

The primary endpoint describes the number of patients who has completed week 12 of treatment with ITF2357, both in the Per protocol (PP) population and in the Intention to treat (ITT) population. ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength. Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity.

次要结局

  • JIA Outcome Core Set Variables - Number of Joints With Active Arthritis(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • JIA Outcome Core Set Variables - Number of Joints With Limitation(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • JIA Outcome Core Set Variables - CHAQ(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • JIA Outcome Core Set Variables - ESR(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • JIA Outcome Core Set Variables - Patient Global Assessment(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • JIA Outcome Core Set Variables - Physician Global Assessment(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.)
  • Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables(At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month follow-up (FU1) in the PP and ITT populations respectively.)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes(Pre-treatment, Weeks 4, 8, 12, and 1-month follow up)
  • Number of Patients With JIA Plus SFS Clinical Improvement(At weeks 2, 4, 6, 8, 10 and 12.)
  • Number of Patients With Sufficient Therapeutic Response at Week 4 to Continue Treatment(At week 4)

研究者

发起方
Italfarmaco
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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