A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Co-primary criteria: observance and health assessment questionnaire
研究概览
简要总结
The primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult patient (18 years or over) of either sex.
- •With established rheumatoid arthritis diagnosis
- •Treated for rheumatoid arthritis by methotrexate (oral or by injection) since at least 3 months regardless of the prior or combined disease modifying treatment, except biotherapies and justifying injection of methotrexate. For the patient treated by oral methotrexate, the switch decided by the rheumatologist is made for either safety, compliance or efficacy issues.
- •Agreeing to participate in the study and having dated and signed the informed consent form.
排除标准
- •Patients fulfilling one or more of the following exclusion criteria will not be included in the study:
- •Inability of patient to use an auto-injector.
- •Treated with biotherapies.
- •Pregnant or breast-feeding patients
- •Male and female patients with reproductive potential who are not willing to use effective method of contraception (oral contraceptives, intrauterine device, condoms) during study and at least 1 month after the end of the study.
- •Patients with :
- •hypersensitivity to methotrexate or to any of the excipients,
- •severe hepatic impairment,
- •alcohol abuse,
- •severe renal impairment,
- •pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia,
- •Immunodeficiency,
- •serious, acute or chronic infections such as tuberculosis and HIV,
- •stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease,
- •concurrent vaccination with live vaccines.
- •Association with probenecid, trimethoprim, phenylbutazone.
- •Any other known medical or surgical history, disorder or disease judged by the investigator to be incompatible with the study (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasia, haematological, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc...),
- •Inability of patient to understand the study procedures and thus inability to give informed consent.
- •Participation in another clinical study, at the same time as the present study, or during the month following the end of the previous study
- •Ward of court.
- •Patient not covered by the Social Security.
研究组 & 干预措施
Auto-injector of methotrexate
The Auto-injector is a disposable, fixed, single dose, auto-injector to be used for Methotrexate (25mg/ml) therapy.
Dosage form: solution for injection Dosage: 0.3ml contains 7.5mg of Methotrexate, 0.4ml contains the 10.0mg of Methotrexate, 0.6ml contains 15.0 mg of Methotrexate, 0.8ml contains 20.0 mg of Methotrexate, 1.0ml contains 25.0 mg of Methotrexate.
Frequency: one injection per week Duration: until the end of the study
干预措施: Methotrexate (Drug)
Pre-filled syringe of methotrexate
Pre-filled syringes contains a volume of 1 ml with attached injection needle. Dosage form: solution for injection. Dosage: 0.15 ml contains 7.5 mg of methotrexate, 20 ml contains 10 mg of methotrexate, 0.30 ml contains 15 mg of methotrexate, 0.40 ml contains 20 mg of methotrexate, 0.50 ml contains 25 mg of methotrexate disodium.
Frequency: one injection per week Duration: until the end of the study
干预措施: Methotrexate (Drug)
结局指标
主要结局
Co-primary criteria: observance and health assessment questionnaire
时间窗: 6 months
the health assessment questionnaire is completed by the patient at inclusion visit and at the 6 months visit. Compliance with methotrexate treatment will be assessed by the investigator at each visit
次要结局
- quality of life(6 months)
- acceptability(up to 1 year)
- preference(6 months)
- Economic(6 months)