CTRI/2022/10/046212进行中（未招募）3 期
Comparative pharmacokinetic, pharmacodynamic,safety, efficacy and immunogenecity study ofVBRTXM01 (Virchow Rituximab) versus Ristova(Roche Rituximab) in patients with RheumatoidArthritis - Nil
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female patients aged between 18 – 60 years (both inclusive).
- •2.History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification, for at least 6 months.
- •3.Moderate to severe active RA seropositive disease.
- •4.History of treatment with Methotrexate (MTX) 20-25mg per week for at least 12 weeks with last 4 weeks at the stable dose before screening.
- •5.If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period.
- •6.Able and willing to give written informed consent and comply with the requirements of the study protocol procedures.
排除标准
- •1.Patients with significant systemic manifestations of RA.
- •2.Female nursing patients.
- •3.Rheumatic autoimmune disease other than RA.
- •4.History of diagnosis of juvenile idiopathic arthritis (also known as juvenile rheumatoid arthritis) and/or RA before age 16.
- •5.History of inflammatory arthritis other than RA (e.g., inflammatory bowel disease, systemic lupus erythematosus (SLE), or psoriatic arthritis).
- •6.Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
- •7.Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA2.
- •8.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for infliximab, adalimumab, or leflunomide).
- •9.Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
- •10.Previous treatment with Rituximab.
- •11.Previous treatment with any cell-depleting therapies, including investigational agents.
- •12.Treatment with IV gamma-globulin or plasma filtering device like Prosorba (R) Column within the previous 6 months.
- •13.Receipt of a live vaccine within 4 weeks prior to Day 1 infusion.
- •14.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •15.History of primary or secondary immunodeficiency
- •16.Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation.
- •17.Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds).
- •18.History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- •19.History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
- •20.Lack of peripheral venous access.
- •21.History of chronic daily use of narcotic analgesics.
- •22.History of alcohol, drug, or chemical abuse within 6 months prior to screening.
- •23.Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
- •24.History of significant cytopenias or other bone marrow disorders.
- •25.Laboratory Exclusion Criteria: Patients with following abnormal values will be excluded :
- •a.Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for men.
- •b.AST or ALT > 2.5 times upper limit of normal.
- •c.Platelet count < 100,000/µL.
- •d.Hemoglobin < 8.0 g/dL.
- •e.Neutrophils < 1.5 × 103/µL.
- •f.IgG <6 g/L
研究者
相似试验
尚未招募
3 期
Comparative biosimilar Denosumab versus Xgeva in patients with bone metastasis from solid tumoursCTRI/2024/06/068269Virchow Biotech Private Limited
已完成
不适用
Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)CancerISRCTN75734403Medac GmbH (Germany)32
已完成
1 期
FarmaPEG-Ione. Healthy volunteers.Healthy VolunteersRPCEC00000039Center for Genetic Engineering and Biotechnology (CIGB)16
招募中
1 期
Comparative pharmacodynamics and pharmacokinetics study of generic and reference clopidogrel products in Thai Healthy volunteersAntiplatelet AgentsClopidogrelPlatelet inhibitionPlatelet aggregationTCTR20131204001Khon Kaen University30
已完成
不适用
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery Diseaseillness of coronary arteries10011082Coronary Artery DiseaseNL-OMON34026Eli Lilly25