NCT02565810已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
研究概览
简要总结
A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female aged 18-55 years at the time of signing the informed consent form.
- •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.
- •Subjects who are considered by the Investigator to be a suitable candidate for self-administering adalimumab treatment
- •Must be able to provide informed consent, which must be obtained prior to any study related procedures.
排除标准
- •Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
- •Have a known hypersensitivity to human immunoglobulin proteins or other components of SB
- •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.
- •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.
- •Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
- •Have any of the following conditions:
- •History of congestive heart failure (New York Heart Association Class III/IV)
- •History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
- •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.
- •History of lymphoproliferative disease including lymphoma or melanoma.
- •Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
研究组 & 干预措施
SB5 40mg
Experimental
干预措施: Adalimumab PFS and Pen (Drug)
结局指标
主要结局
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
时间窗: Difference of injection site pain score (Week 6 - Week 2)
Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.
次要结局
- Overall Impression of SC Delivery Administration of SB5 Using Questionnaire(at Week 2 and at Week 6)
- Subject Preference of SC Delivery Administration of SB5 Using Questionnaire(at Week 6)
研究者
研究点 (2)
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