EUCTR2014-004887-39-PL进行中（未招募）不适用
An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Are male or female aged 18–55 years at the time of signing the informed consent form.
- •2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.
- •3. Subjects who are considered by the Investigator to be a suitable candidate for selfadministering adalimumab treatment
- •4. Must be able to provide informed consent, which must be obtained prior to any study related procedures.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
- •2. Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.
- •3. Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB indicated by a positive QuantiFERON® Gold test result.
- •4. Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.
- •5. Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
- •6. Have any of the following conditions:
- •a. History of congestive heart failure (New York Heart Association Class III/IV)
- •b. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
- •c. History of any malignancy (other than lymphoproliferative disease and melanoma, see Exclusion Criteria 10.f) within the previous 5 years prior to Screening except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
- •d. History of lymphoproliferative disease including lymphoma or melanoma.
- •e. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
研究者
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