A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 14
- 主要终点
- Mean Injection Site Pain on a Visual Analogue Scale (VAS)
研究概览
简要总结
This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and Germany (2 sites).
详细描述
61 participants were randomized, and 60 received at least one dose of the study drug. One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm of the study, discontinued from the study and never received study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject age 18 years or older, who requires Humira 40 mg SC every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local Humira label.
- •Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic naïve subject who requires initiation of on-label treatment with Humira.
- •Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACR classification criteria or the ACR/EULAR 2010 criteria,
- •Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug.
- •All female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at Screening and prior to study drug dosing on a urine sample obtained at Visit 1.
排除标准
- •Subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit
- •Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Visit 1 or oral anti-infectives within 14 days prior to Visit
- •Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
- •Known hypersensitivity to adalimumab or its excipients.
- •History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
结局指标
主要结局
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
时间窗: Immediately after injection.
The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.
次要结局
- Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale(10 minutes and 30 minutes after injection)
- Percentage of Participants With no Erythema in the Draize Scale(10 minutes and 30 minutes after injection)
- Percentage of Participants With no Pruritus in the Draize Scale(10 minutes and 30 minutes after injection)
- Mean Injection Site Pain on a Visual Analogue Scale (VAS)(15 minutes post injection)
- Percentage of Participants With no Edema in the Draize Scale(10 minutes and 30 minutes after injection)
- Number of Participants With Adverse Events (AEs)(Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.)