Advanced Therapeutics in Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Retention Rates
研究概览
简要总结
This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).
详细描述
Conventional therapies for Rheumatoid Arthritis (RA) treatment include nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) selective inhibitors, corticosteroids and disease modifying anti-rheumatic drugs (DMARDs). These therapies are often partially effective.
For those patients, where conventional therapies have failed to alleviate their symptoms, Tumour Necrosis Factor (TNFis) is often prescribed to treat the pain and inflammation associated with RA. The main problem with TNFi and other advanced therapies in RA is retention. At least ¼ of patients stop treatment within a year and another ⅕ to ¼ in the second year, mostly due to secondary loss of efficacy.
Another advanced therapy, the Janus kinase inhibitor (JAK) has demonstrated similar efficacy to TNFi treatment in RA. This trial will determine if using a different class of treatment (small molecule, oral drug, JAK kinase inhibitor) will have a better retention than a TNFi (using the most commonly prescribed TNFi for RA in Canada).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •patients with RA who meet criteria for obtaining an advanced therapeutic through usual care
- •active RA with 5 or more swollen joints
- •seropositive
- •presence of erosions
- •failure of methotrexate and hydroxychloroquine and sulfasalazine
- •failure of Leflunomide
- •> or equal to 18 years
- •able to provide consent
- •able to attend usual follow up visits
排除标准
- •no contraindication to etanercept or tofacitinib
- •active serious infection
- •active Tuberculosis
- •multiple sclerosis
- •current cancer
- •lymphoma ever
- •previous use of an advanced therapeutic (biologic or JAK kinase inhibitor)
- •less than 18 years of age
- •unable to provide consent
研究组 & 干预措施
etanercept
etanercept 50 mg subcutaneously injected per week
干预措施: Etanercept (Drug)
tofacitinib
tofacitinib 5 mg orally daily
干预措施: tofacitinib (Drug)
结局指标
主要结局
Retention Rates
时间窗: 24 months
Evaluation of the proportion of patients in each arm still on the randomized treatment
次要结局
- Mean Change in Disease Activity(24 months)