EUCTR2012-003194-25-HR进行中（未招募）1 期
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: 2014年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
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 Rheumatoid Arthritis diagnosed according to revised 1987 American Rheumatism Association (ARA)
- •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 biological agents 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
- •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 (systemic lupus erythematosus [SLE], scleroderma, inflammatory bowel
- •disease, severe vasculitis, pulmonary fibrosis, Felty’s syndrome)
- •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), 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
- •· 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
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