EUCTR2016-002716-41-FR进行中（未招募）1 期
AN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE SAS
- 入组人数
- 10
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
- •1.Able and willing to provide written informed consent and to comply with the requirements of the study protocol.
- •2.Patient who completed the 156-week WA28119 core study in France.
- •3.Patient who experienced at any time during WA28119 core study a clinical improvement based on the investigator’s judgment, and may continue to benefit from SC TCZ in this study.
- •4.Patient whom the investigator wants to treat with SC TCZ for one of the following reasons:
- •Persistent active GCA at the time of completion of the 156-week WA28119 core study.
- •New flare occurring within 3 years after completion of the 156-week WA28119 core study
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Patients who have prematurely withdrawn from the WA28119 core study for any reason
- •2.Major surgery within 8 weeks prior to screening or planned major surgery within the next 12 months
- •3.Major ischemic event, unrelated to GCA, within 12 weeks of inclusion
- •4.Transplanted organs (except corneal transplant performed more than 3 months prior to inclusion)
- •5.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
- •6.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or Gastrointestinal (GI) disease
- •7.Current liver disease, as determined by the investigator (ie. Positive hepatitis B surface antigen or hepatitis C antibody)
- •8.History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
- •9.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- •10.Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of inclusion or oral antibiotics within 2 weeks of inclusion.
- •11.Active TB requiring treatment within the previous 3 years.
- •Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible.
- •12.Primary or secondary immunodeficiency (history of or currently active)
- •13.Evidence of malignant disease or malignancies diagnosed since last WA28119 visit (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
- •14.Females of childbearing potential and females who are breastfeeding
- •15.Males of reproductive potential who are not willing to use an effective method of contraception, such as condom, sterilization, or true abstinence throughout study and for a minimum of 6 months after study drug therapy.
- •16.History of alcohol, drug, or chemical abuse within 1 year prior to inclusion
- •17.Body weight > 150 kg
- •Exclusion Related to Previous or Concomitant Therapy
- •18.Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of inclusion (except TCZ)
- •19.Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
- •20.Treatment with IV gamma globulin or plasmapheresis within 6 months of inclusion
- •21.Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
- •22.Immunization with a live/attenuated vaccine within = 4 weeks prior to inclusion
- •23.Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or MMF within 4 weeks of inclusion
- •24.Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of inclusion
- •25.Previous treatment with tofacitinib
- •26.Treatment with cyclophosphamide within
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