A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - *-SPECIFIC 2

ovartis0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: ovartis
入组人数: 10

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 99（—）

入选标准

•1. Parent*s or legal guardian*s written informed consent and child*s assent, if appropriate, or
•patient*s informed consent for * 18 years of age before any study related activity is
•2. Male and female patients aged * 2 to < 20 years at the time of the screening visit
•3. Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al 2004) that must have
•occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age:
•* Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration
•that is documented to be daily/ quotidian for at least 3 days and accompanied by one
•or more of the following:
•* Evanescent nonfixed erythematous rash,
•* Generalized lymph node enlargement,
•* Hepatomegaly and/ or splenomegaly,
•* Serositis
•4. Active disease at the time of enrollment defined as follows:
•* At least 2 joints with active arthritis (using ACR definition of active joint) (Not
•required for CACZ885G2305 roll-over patients)
•* Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day
•during the screening period within 1 week before first canakinumab/placebo dose
•(Patients rolling-over from the CACZ885A2203 or CACZ885G2305 study will not be
•required to have fever for study entry)
•* C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) (Patients rolling-over
•from the CACZ885A2203 or CACZ885G2305 study will not be
•required to have a CRP > 30 mg/L)
•5. Patient*s willingness to discontinue anakinra, rilonacept, tocilizumab or other
•experimental drug under close monitoring (Please refer to Section 5.2 - Exclusion criteria
•#12 for washout period.)
•6. No concomitant use of second line agents such as disease-modifying and/or
•immunosuppressive drugs will be allowed with the exception of:
•* Stable dose of methotrexate (maximum of 20 mg/ m2/ week) for at least 8 weeks prior
•to the screening visit, and folic/folinic acid supplementation (according to standard
•medical practice of the center)
•* Stable dose of no more than one non-steroidal anti-inflammatory drug (NSAID) for at
•least 2 weeks prior to the screening visit
•* Stable dose of steroid treatment * 1.0 mg/kg/day (maximum 60 mg/day for children
•over 60 kg) in 1-2 doses per day of oral prednisone (or equivalent) for at least 3 days prior to baseline (Day 1)
•7. Negative Purified Protein Derivative (PPD) test (< 5 mm induration) or negative
•QuantiFERON at screening or within 1 month prior to the screening visit, according to the
•national guidelines. Patients with a positive PPD test (* 5 mm induration) at screening
•may be enrolled only if they have either a negative chest x-ray or a negative
•QuantiFERON test (QFT-TB G In-Tube). If the patient has a history of Bacillus Calmette-
•Guérin (BCG) vaccination, then a QuantiFERON test should be performed in place of a
•PPD test. (Not required for CACZ885G2305 roll-over patients)
•8. Patients who have completed study CACZ885A2203 and flared * 6 months after their last
•canakinumab dose will be considered *treatment-naïve* patients and will be required to
•meet all inclusion/exclusion criteria of CACZ885G2301 protocol.

排除标准

•1. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of
•a female after conception and until the termination of gestation, confirmed by a positive
•hCG laboratory test (> 5 mIU/ mL) at screening visit
•2. Female patients having reached sexual maturity (e.g. Tanner stage 2 or above), i.e. being
•physiologically capable of becoming pregnant UNLESS they are:
•* female patients whose career, lifestyle, or sexual orientation precludes intercourse
•with a male partner and/or
•* using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
•Reliable contraception should be maintained throughout the study and for 2 months
•after study drug discontinuation.
•3. History of hypersensitivity to study drug or to biologics.
•4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni
•and Pistorio 2005) within the last 6 months
•5. With active or recurrent bacterial, fungal or viral infection at the time of enrollment,
•including patients with evidence of Human Immunodeficiency Virus (HIV) infection,
•Hepatitis B and Hepatitis C infection
•6. Any of the risk factors for tuberculosis (TB) such as:
•* History of any of the following: residence in a congregate setting (e.g. jail or prison,
•homeless shelter, or chronic care facility), substance abuse (e.g. injection or
•noninjection); health-care workers with unprotected exposure to patients who are at
•high risk of TB or patients with TB disease before the identification and correct
•airborne precautions of the patient, or
•* Close contact (i.e. share the same air space in a household or other enclosed
•environment for a prolonged period (days or weeks, not minutes or hours)) with a
•person with active pulmonary TB disease within the last year
•7. With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which
•in the opinion of the investigator immunocompromises the patient and/ or places the
•patient at unacceptable risk for participation in an immunomodulatory therapy. In
•particular, clinical evidence or history of multiple sclerosis or other demyelinating
•diseases, or Felty*s syndrome.
•8. With significant medical conditions, which in the opinion of the Investigator will exclude
•the patient from the study (can be discussed on a case by case basis with Novartis)
•9. History of malignancy of any organ system (other than localized basal cell carcinoma of
•the skin), treated or untreated, within the past 5 years, regardless of whether there is
•evidence of local recurrence or metastases
•10. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function
•tests at screening such as AST, ALT, GGT, alkaline phosphatase, or serum bilirubin (must
•not exceed twice the upper limit value of the normal range for age)
•11. Presence of moderate to severe impaired renal function as indicated by clinically
•significantly abnormal creatinine (* 1.5 x upper normal limit (ULN)) or urea values or
•abnormal urinary constituents (e.g., albuminuria) at screening. Evidence of urinary
•obstruction or difficulty in voiding at screening.
•12. Use of the following therapies:
•* Anakinra within 24 hours prior to Baseline visit
•* Rilonacept within 1 week prior to Baseline visit
•* Tocilizumab within 3 weeks prior to Baseline visit
•* Etanercept

研究者

发起方

ovartis

相似试验

进行中（未招募）

不适用

A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA

EUCTR2008-005479-82-Outside-EU/EEAovartis Pharma Services AG177

进行中（未招募）

不适用

EUCTR2008-005479-82-ATovartis Pharma Services AG214

进行中（未招募）

不适用

A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis

EUCTR2008-005479-82-GRovartis Pharma Services AG214

进行中（未招募）

不适用

EUCTR2008-005479-82-HUovartis Pharma Services AG214

进行中（未招募）

不适用

EUCTR2008-005479-82-DEovartis Pharma Services AG214