Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 21
- 主要终点
- rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.
研究概览
简要总结
To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.
详细描述
Patients suffering from rheumatoid polyarthritis have an increased risk to develop an infection compared to general population, with a more important mortality risk because pneumococcus is considered as one of the major pathogenic agents. Antipneumcoccal vaccination is recommended to patients suffering from chronic inflammatory rheumatism treated with immunosuppressants. Methotrexate is a long term treatment used in first intention for rheumatoid polyarthritis. A recent study shows a decrease of efficacity of antipneumoccal vaccination for patients suffering from rheumatoid polyarthritis treated by methotrexate. The tested hypothesis will be the presence of better vaccinal protection for patients suffered from rheumatoid polyarthritis after 1 month between antipneumococcal vaccination and the initiation of methotrexate. The objective is to compare immunologic response for antipneumococcal vaccination between patients who are vaccinated in the same time of initiation of methotrexate and patients who are vaccinated 1 month before the beginning of the treatment.
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
- •Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria
- •Rheumatoid arthritis considering 3,2<DAS<5,1
- •Patient did not treat by long term treatment or has stopped a treatment by sulfasalazine, hydroxychloroquine or methotrexate for at least 3 months
- •Patient has never treated by biotherapy
- •Patient has never vaccinated against pneumococcal
- •Patient has signed study consent form
排除标准
- •Patient has ever treated by leflunomide or has treated previously by leflunomide (last 3 months)
- •Patient is currently treated by methotrexate or has treated previously by methotrexate (last 3 months)
- •Contraindication to methotrexate: renal insuffisance, alcoolic, chronic hepatisis, infectious condition, AIDS, hematological failure (cytopeny), pregnancy, obesity, diabet, respiratory disease, gastric ulcer
- •Contraindication to corticotherapy
- •Pregnancy or pregancy wish
- •Absence of oral contraception for women of childbearing age
- •Patient of age protected by law et deprived of liberty
- •Subject who refuses to be vaccinated against pneumococcis agent
- •Previous history of vaccination allergy (anaphylactic shok, Quincke oedema...)
- •Gluten hypersensivity or intolerance
- •Other vaccination during the last month before inclusion
- •Ig perfusion during the last 3 months period before the study inclusion or during the study duration
- •Patient currently treated by anticoagulant or has not been stopped for at least 48h before the study inclusion or hemostasis failure which is contraindicated with muscular injection
- •Participation with an other clinical trial
研究组 & 干预措施
Immediate group
For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination.
Interventions : biological/vaccine and drug
干预措施: Prevenar 13 (Biological)
Immediate group
For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination.
Interventions : biological/vaccine and drug
干预措施: Pneumo23 / Pneumovax (Biological)
Immediate group
For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination.
Interventions : biological/vaccine and drug
干预措施: Methotrexate - Immediate (Drug)
period group
Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13.
A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination
Interventions : biological/vaccine and drug
干预措施: Prevenar 13 (Biological)
period group
Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13.
A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination
Interventions : biological/vaccine and drug
干预措施: Pneumo23 / Pneumovax (Biological)
period group
Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13.
A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination
Interventions : biological/vaccine and drug
干预措施: Methotrexate - Delay (Drug)
结局指标
主要结局
rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.
时间窗: 1 month
Patient who begins a treatement by methotrexate either in the same time, either 1 month later. An answer will be considered as positive if the patient answers in at least 3 on 5 of interest serotypes.
次要结局
- Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)(1 month)
- Frequency of occurence of disease spurts from the first vaccination until the end of the study(Up to 12 months)
- Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)(1 month)
- occurence of the pneumococcal disease from the first vaccination to the end of the study.(1, 6, 7 and 12 months)
- Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination(up to 12 months)
- Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.(3, 6 and 12 months)