Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 主要终点
- Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
研究概览
简要总结
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 patients, >=18 years of age;
- •rheumatoid arthritis >=6 months;
- •lack of response to 1-5 DMARDs or biological agents;
- •rheumatoid factor positive.
排除标准
- •other chronic inflammatory articular disease or systemic rheumatic disease;
- •joint or bone surgery during 8 weeks prior to randomization;
- •previous treatment with any cell-depleting therapy.
研究组 & 干预措施
Rituximab
Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
干预措施: Methotrexate (Drug)
Rituximab
Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
时间窗: Up to Week 48
An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.
Number of Participants With AEs According to Degree of Intensity
时间窗: Up to Week 48
An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).
Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs
时间窗: Up to Week 48
An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification "Yes" and "No". A relationship classified as "Yes" implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments.
Number of Participants With AEs of Special Interest During the Study
时间窗: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)
Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.
次要结局
- Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Duration of Morning Joint Stiffness(Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48))
- Mean Value of Painful Joints(Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48))
- Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria(Week 1, Week 12, and Week 24)
- Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of C Reactive Protein(Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48))
- Mean Values of Globular Sedimentation Velocity(Screening ((Days -28 to 0), Week 1, Week 12, and Week 24)
- Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Pain and Activity Based on Visual Analogue Scale(Screening ((Days -28 to 0), Week 1, Week 12, and Week 24)
- Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit(Screening (Days -28 to 0) and EOT (Week 24))
- Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)(Screening (Days -28 to 0), Week 1, Week 12, and Week 24)
- Mean Value of Inflamed Joints(Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48))