EUCTR2012-003194-25-LT进行中（未招募）不适用
Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis
Mabion S.A.0 个研究点目标入组 863 人开始时间: 2012年9月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 863
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient/subject must meet all of the following inclusion criteria to be enrolled in the study:
- •1. Able to provide written informed consent after receiving information about benefits and potential risks of the trial, as
- •well as details of the insurance covering the subjects participating in the study
- •2. Caucasian males and females ³ 18 up to 80 years old
- •3. Body Surface Area (BSA) between 1.5 – 2.2 m2 calculated according to the DuBois & DuBois formula : BSA in m2 =
- •(Weight (kg) 0.425 x Height (cm) 0.725) x 0.007184
- •4. Patients with active rheumatoid arthritis diagnosed according to revised 1987 American Rheumatism Association criteria (Appendix 3), with disease duration minimum 6 months prior to screening visit, who are naive to tumor necrosis factor (TNF) antagonists or any other monoclonal antibody therapies and who have had an inadequate response to an adequate regimen of methotrexate or/and other disease modifying anti-rheumatic drugs (DMARDs);
- •5. Patients with moderate to severe active RA defined as the presence of the following:
- •· ³ 8 swollen joints and ³ 8 tender joints, observed by a physician at the screening
- •· radiographic evidence of ³ 1 joint with define erosion attributable to RA and 2 or more of the following:
- •· serum C-reactive protein (CRP) ³ 6 mg/L
- •· erythrocyte sedimentation rate (ESR) ³ 28 mm/hr
- •· morning stiffness in and around joints lasting longer than 45 minutes
- •6. Patients on methotrexate treatment receiving 10-25 mg /week for at least 12 weeks, with the last 4 weeks at a stable
- •7. Negative serum pregnancy test for women of childbearing potential
- •8. Female and male (or her/his partner) of childbearing potential willing to use acceptable forms of contraception (e.g.,
- •hormonal contraceptive, contraceptive patch, intrauterine device, double- barrier method (condom or diaphragm with
- •spermicide, surgical sterilization, partner’s vasectomy) starting from screening and until 12 months following the last
- •9. Ability and willingness to comply with the requirements of the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 647
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 216
排除标准
- •Patients meeting any of the following exclusion criteria [12] are not to be enrolled:
- •1. History of or current rheumatic autoimmune disease other than RA eg. Juvenile Idiopathic Arthritis (except
- •concurrent Sjogren’s syndrome)
- •2. History of or current inflammatory joint disease other than RA
- •3. American College for Rheumatology functional Class IV disease
- •4. History of significant systemic involvement secondary to RA like severe vasculitis, pulmonary fibrosis, Felty’s syndrome or other immunological disorders eg. systemic lupus erythematosus [SLE], scleroderma, inflammatory bowel disease,
- •5. Inability to understand the written and verbal instructions, in particular the risks connected with the study
- •6. History of psychiatric disorder that would interfere with normal participation in this protocol
- •7. Subject has known positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
- •8. Serious and uncontrolled coexisting diseases which, in the Investigator's opinion, would preclude subject participation. These may include but are not limited to:
- •· Known cardiopulmonary disease, e.g. coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure, i.e. satisfying criteria for the New York Heart Association [NYHA] classes III or IV
- •· Serious and uncontrolled pulmonary diseases (chronic, latent and acute infections of the lung, obstructive pulmonary disease)
- •· History of or currently treated serious central nervous system/neurological disorders
- •· Any neurological (congenital or acquired), vascular or systemic disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., neuropathies and neurovasculopathies, Parkinson’s disease, cerebral palsy, diabetic neuropathy)
- •· Serious disorders of the renal, hepatic, endocrine, or gastrointestinal system
- •· Active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis, sepsis, opportunistic infections) but excluding fungal infections of nail beds
- •· History of recurrent clinically significant infection
- •· History of tuberculosis or latent tuberculosis tested and confirmed according to the local standards and regulations and/or positive result of Chest X-ray for tuberculosis at screening or within last 6 months prior to screening.
- •· History of cancer including solid tumors, haematologic malignancies, without recovery /remission within 5 years prior to screening, except basal cell and squamous cell carcinoma of the skin that have been excised and cured and treated cervical cancer in situ.
- •· History of significant cytopenia or other serious bone marrow disorders
- •· Primary or secondary immunodeficiency
- •· History of drug, alcohol, or chemical abuse within 2 years prior to screening
- •· Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •9. Serious abnormal laboratory findings, specifically:
- •· Neutrophil count < 1.500 / µL
- •· Platelet count < 75.000 / µL
- •· Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal
- •· Hemoglobin <8.0 g/dL
- •· IgG below 5.0 mg/mL or IgM below 0.4 mg/mL
- •· Any other serious laboratory abnormality
- •10. Prior tre
研究者
相似试验
进行中（未招募）
1 期
Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid ArthritisActive Rheumatoid ArthritisMedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-003194-25-HRMabion S.A.863
进行中（未招募）
不适用
Randomised, double-blind, parallel-group, comparative study of two terbinafine productsEUCTR2008-007067-16-CZJELFA SA
已完成
不适用
Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean feverfamilial Mediterranean feverJPRN-UMIN000028010Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences23
进行中（未招募）
1 期
A double-blind, randomized, parallel group comparison of Nizoral® cream (F012), ketoconazole 2% cream (F126) and placebo (F000) in the treatment of interdigital Tinea Pedis. - Ketoconazole cream formulations in Tinea pedisFor the treatment of tinea pedisEUCTR2006-006513-33-GBJanssen Pharmaceutica NV
尚未招募
3 期
A clinical trial of herbal products in the management of knee osteoarthritisCTRI/2023/07/054799Phytoveda Pvt. Ltd.