2025-522319-41-00招募中4 期
Non-inferiority study of TOCILIZUMAB in dose-banding versus dose-weight in rheumatoid arthritis with low activity or clinical remission
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:
研究概览
简要总结
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria
- •Rheumatoid arthritis with low disease activity or remission according to DAS28 ...
- •Patient to receive a TOCILIZUMAB infusion at 8 mg/kg
- •Patient failing treatment with cDMARDs or bDMARDs
- •Allowed concomitant treatment(s) for rheumatism: stable doses for at least 3 months of cDMARDs, NSAIDs, analgesics, or corticosteroids (< 10 mg/day of prednisone equivalent)
- •Signing of the informed consent
- •Affiliation to a social security scheme
排除标准
- •Active neoplasm
- •Treatment with TOCILIZUMAB for an indication other than rheumatoid arthritis
- •Treatment with TOCILIZUMAB at a dosage other than 8 mg/kg
- •Diverticulitis or history of digestive perforation
- •Ongoing pregnancy. A blood pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
- •Active hepatitis B
- •Untreated latent tuberculosis
- •Severe or active infection (except for COVID-19)
- •Vulnerable individuals: minors, adults under guardianship or curatorship
结局指标
主要结局
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:
The non-inferiority of TOCILIZUMAB in dose-banding will be evaluated through the study of the changes in the DAS28 activity score. The change in this activity score between M0 and M3 will be calculated:
次要结局
- The cost of preparing the bags is estimated based on the preparation time, corresponding to the sum of the sterilization, production, and bag release times over the 3 months of the study in each of the 2 groups. The total cost over the 3 months of the study will then be divided by the number of infusions to be administered in order to obtain a cost per infusion in each group.
- 2. The pharmaceutical release time will be defined as the time in minutes between medical approval, determined by the production of the prescription, and approval for transport to the department. ...
- The non-reallocation rate will be defined by the number of unused bags over the number of reallocated bags.
研究者
Pr ROUX Christian
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (2)
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