EUCTR2012-005026-30-HU进行中（未招募）1 期
A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 596
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
- •1. Are male or female aged 18–75 years at the time of signing the consent form.
- •2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria
- •3. Have more than or equal to six swollen joints, more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation and either erythrocyte sedimentation rate (Westergren) = 28 mm/h or serum C-reactive protein = 1.0 mg/dL at Screening.
- •4. Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10–25 mg/week given orally or parenterally for at least 4 weeks prior to Screening.
- •5. Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product (IP).
- •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 438
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
- •2. Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4.
- •3. Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
- •4. Have a current diagnosis of active tuberculosis
- •5. Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
- •6. Have any of the following conditions
- •a. Other inflammatory or rheumatic diseases.
- •b. History of any malignancy within the previous 5 years prior to Screening
- •c. History of lymphoproliferative disease including lymphoma.
- •d. History of congestive heart failure
- •e. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
- •f History of demyelinating disorders.
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