EUCTR2017-000519-18-FR进行中（未招募）1 期
PIMOC : Personalized targeted therapies in inflammatory complex multi organ disease - PIMOC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Patients (men or women) aged 18 years old and over
- •-Patients presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract. Skin involvement is mandatory in order to be able to compare involved and non involved tissue
- •-Signed informed consent
- •The disease should be considered as non-classified despite classical and adapted investigations and evaluation through expert committee meeting.
- •The disease alters significantly quality of life using SF36 assessment : score less than 30.
- •The disease has been resistant to at least two prior lines of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •-Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy
- •-Patients refusing biopsies
- •-Pregnancy
- •-Women of child-bearing potential unable to receive highly efficient contraception such as combined oral contraceptives, intra-uterine disposals, hormonal implants or the use of male condoms recommended in case of unstable or irregular partner or as a replacement method for transient unacessebility to hormonal method
- •-Breastfeeding
- •-Patients presenting disease needing urgent therapeutic measures
- •-Patients without health insurance or social security
- •-Patients under legal protection
- •-Participation in another interventional trial
- •-Patients unable to respect the wash out delay of previously taken medications before inclusion time :
- •*Hydroxychloroquine (wash out period = 30 days)
- •*Chloroquine (wash out period = 7 days)
- •*Colchicine (wash out period = 7 days)
- •*Methotrexate (wash out period = 7 days)
- •*Ciclosporine (wash out period = 14 days)
- •*Azathioprine (wash out period = 14 days)
- •*Mycophenolate mofetil (wash out period = 14 days)
- •*Disulone (wash out period = 7 days)
- •*Corticosteroids (=prednisone, prednisolone, dexamethasone, methylprednisolone) (wash out period = 7 days)
- •-Patients with contra-indications to treatments: Severe or active infections including tuberculosis
- •Importantly, in this study, the treatment will be selected by a committee depending on three criteria (cf Design of the trial: Interpretation of the data) including contra indications of the patients to the drugs. Therefore, contra indicated medications cannot be selected by the committee in view of protocol participation.
研究者
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