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临床试验/EUCTR2017-001717-92-AT
EUCTR2017-001717-92-AT进行中（未招募）1 期

A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA

Medical University of Vienna0 个研究点目标入组 24 人开始时间: 2017年8月17日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
24
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 clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •18 - 70 years at screening
  • •Written informed consent
  • •Weigh =50.0 kg and =100.0 kg at screening
  • •Diagnosis of RA according to the 2010 ACR/EULAR classification criteria for RA
  • •at least one conventional synthetic (cs)DMARD (methotrexate (MTX), leflunomide, sulfasalazine (SSZ)) regularly for at least 12 weeks, with stable doses for at least 8 weeks.
  • •moderately to severely active RA
  • •Received at least one TNF-inhibitor (TNFi) but not more than 3 biological (b)DMARDs and discontinued treatment because of an insufficient response after at least 3 months.
  • •Oral Glucocorticoids (OCS) are allowed at stable doses of =10 mg /day prednisone or equivalent, if already used before the screening visit, dose must be stable for at least 2 weeks
  • •High type I IFN gene signature test
  • •Seronegative for HIV, hep. B surface antigen and hep. C ¬antibodies
  • •Negative serum ß-hCG test at screening (females of childbearing potential only).
  • •Females of childbearing potential must use 2 effective methods of avoiding pregnancy
  • •All males (sterilised or non-sterilised) who are sexually active must use condom (with spermicide where commercially available)
  • •Male subjects must not donate sperm during the course of the study and for 12 weeks after the last dose of the investigational product.
  • •Females with an intact cervix must have documentation of a normal Pap smear with no documented malignancy
  • •Meets all of the following tuberculosis (TB) criteria:
  • •-No history of latent or active TB, exception: latent TB with documented completion of appropriate treatment
  • •-No signs or symptoms suggestive of active TB
  • •-No recent contact with a person with active TB
  • •-Negative QuantiFERON-tuberculosis Gold [QFT-G] test for tuberculosis within 3 months prior to randomisation
  • •A chest radiograph with no evidence of current active infection within 12 weeks prior to signing of the informed consent
  • •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 20
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 4

排除标准

  • •General exclusion criteria:
  • •Any condition that would interfere with evaluation of the investigational product or interpretation of patient safety or study results
  • •Participation in another clinical study with an investigational product
  • •Individuals involved with the conduct of the study, their employees, or immediate family members of such individuals
  • •Lactating or pregnant females or females who intend to become pregnant
  • •Current alcohol, drug or chemical abuse, or a history of such abuse
  • •Major surgery within 8 weeks before signing ICF or elective major surgery planned during the study period
  • •Low type I IFN transcript scores in peripheral whole blood (type I Interfern Gene signature test)
  • •At screening (within 4 weeks before Week 0 [Day 0]), any of the following:
  • •-AST >2.0 × ULN
  • •-ALT >2.0 × ULN
  • •-Total bilirubin >ULN (unless due to Gilbert's syndrome)
  • •-Serum creatinine >2.0 mg/dL (or >181 µmol/L)
  • •-Urine protein/creatinine ratio >2.0 mg/mg (or >226.30 mg/mmol)
  • •-Neutrophil count <1000/µL (or <1.0 × 109/L)
  • •-Platelet count <150.000/µL (or <150 × 109/L)
  • •-Haemoglobin <8 g/dL (or <80 g/L)
  • •-Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic patients only)
  • •Exclusion criteria related to con. Med.:
  • •Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half lives prior to signing of the ICF.
  • •Prior receipt of Anifrolumab
  • •Prior receipt of a JAK-inhibitor
  • •known history of allergy or reaction to any component of the investigational product
  • •Regular use of >1 NSAID within 2 weeks prior to Day 0 OR receipt of fluctuating doses of a NSAID within 2 weeks prior to Day 0
  • •Receipt of any of the following:
  • •-Intra-articular, intramuscular or intravenous glucocorticosteroids within 6 weeks prior to Day 0
  • •-Any live or attenuated vaccine within 8 weeks prior to signing the ICF
  • •-BCG vaccine within 1 year prior signing the ICF
  • •-Blood transfusion within 4 weeks prior signing the ICF
  • •Exclusion criteria related to other diseases:
  • •History of any non RA disease that required treatment with oral or parenteral corticosteroids for > 2 weeks within the last 24 weeks prior signing the ICF
  • •Exclusion criteria related to infection and malignancy risk factors:
  • •Splenectomy
  • •Any severe herpes infection at any time prior to Day 0
  • •Any herpes zoster infection that has not completely resolved within 12 weeks prior signing the ICF
  • •Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of randomisation
  • •Any of the following:
  • •-Clinically significant chronic infection within 8 weeks prior signing the ICF
  • •-Any infection requiring hospitalisation or treatment with intravenous anti infectives not completed at least 4 weeks prior signing the ICF
  • •Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 0
  • •History of cancer, apart from:
  • •-Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy =3 months prior to Week 0 (Day 0)
  • •-Cervical cancer in situ treated with apparent success with curative therapy =1 year prior to Week 0 (Day 0)

研究者

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