Rituximab Objective Outcome Measures Trial in SLE (ROOTS)
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus
This is a feasibility study to test a new trial design for an important drug in Systemic Lupus Erythematosus (SLE or "lupus").
SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of the body may be affected, but most commonly lupus causes a rash and arthritis, this affects patients' quality of life.
Lupus is usually treated with steroids or drugs that suppress the immune system. Although these help, many patients don't respond well enough and there is also concern for long term side effects. There is a new type of treatment called biologics. These target individual cells or molecules rather than the whole immune system and may be more effective with fewer side-effects. B cells are a part of the immune system that are known to play a role in lupus. There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials. However, in lupus clinical trials it did not seem to show any benefit. But many doctors and patients found that rituximab is effective, but the trials couldn't show this because of the way the drug's effects were measured. Therefore it is important that we test whether it truly is effective for lupus.
In this 6 month clinical study the investigators will look at lupus patients who have skin disease and arthritis as these are very common and randomise them to receive either rituximab or a placebo. Patients will have a careful clinical examination and undergo different methods to measure the effectiveness of the treatment. There are new versions to rituximab called "biosimilars". In this study biosimilar GP2013 will be used.
If this trial is successful a larger definitive study will be designed based on its results.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Edward Vital, PhD
- 电话号码：01133924396
- 邮箱：e.m.j.vital@leeds.ac.uk
研究联系人备份
- 姓名：James Goulding, MSc
- 电话号码：01133924396
学习地点
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West Yorkshire
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Leeds、West Yorkshire、英国、LS7 4SA
- 招聘中
- Chapel Allerton Hospital- Leeds Institute for Rheumatic and Musculoskeletal Medicine
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接触：
- Edward Vital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged at least 18 years old
- Active musculoskeletal SLE defined by inflammatory musculoskeletal pain with either clinical synovitis, ultrasound tenosynovitis or positive power Doppler in at least 1 joint
- No contraindication to the use of IV methylprednisolone, biosimilar rituximab, or any other required medications such as antipyretics and antihistamines
- Willing to use appropriate contraception if at risk of pregnancy
- Disease activity that is refractory to hydroxychoroquine, or patients unable to take hydroxychoroquine due to contra-indication or prior toxicity
Exclusion Criteria:
• Severe "critical" SLE flare defined as: (i) BILAG 2004 A flare in CNS system; (ii) BILAG 2004 A flare in the renal system; or (iii) any other SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion
- Pregnancy
- Breast Feeding
- Receipt of daily oral glucocorticoids greater than 10mg prednisolone or equivalent at screening or within the previous 5 days, or change in glucocorticoid dose in the previous 5 days.
- Receipt of intramuscular or intravenous glucocorticoids within the past 4 weeks
- Receipt of intravenous immunoglobulin, plasma exchange or cyclophosphamide within the last 3 months
- Rituximab within the past 18 months or other biologic therapies within the past 6 months
- Active infections, including but not limited to the human immunodeficiency virus, hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or hepatitis C
- Serum IgG below the lower limit of the local laboratory range
- Receipt of a live attenuated vaccine within 3 months prior to study enrolment
- History of cancer in the past 5 years except for squamous or basal cell carcinoma that has been completely excised or treated cervical carcinoma in situ
- In female participants, known history of cervical dysplasia CIN Grade III cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
- Planned surgery within the study period that is expected to require overnight hospital admission
- Any other concomitant medical condition that, in the investigator's opinion, or after discussion with the CI, places the participant at risk by participating in this study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
2 x 1000mg Rituximab and 100mg methylprednisolone
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1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
100mg infusion on days 1 and 15
250ml infusion on days 1 and 15
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安慰剂比较：Control
2 x 100mg methylprednisolone plus placebo
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100mg infusion on days 1 and 15
250ml infusion on days 1 and 15
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of trial considering adherence to protocol, completion of all assessments and visits
大体时间：26 weeks
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Overall feasibility of the trial will be judged based on the feasibility variables.
It is acknowledged that this trial incorporates multiple inter-related aspects of design, with many possible modifications in trials derived from it.
Hence these numbers will be used as a guide only and specific target values have not been defined.
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26 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
大体时间：16 weeks
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An assesment of clinical efficacy of treatment
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16 weeks
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Proportion of patients achieving SLEDAI responder Index (SRI)
大体时间：16 weeks
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An assesment of clinical efficacy of treatment
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16 weeks
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Number of serious adverse events
大体时间：26 weeks
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Safety assessment
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26 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RR15/197
- 2015-002688-40 (EudraCT编号)
- 16/YH/0032 (其他标识符：Research Ethics Committee Reference Number)
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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