A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Samsung Bioepis Co., Ltd.0 个研究点目标入组 584 人开始时间: 2013年7月23日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•1. Are male or female aged 18–75 years at the time of signing the informed consent form.
•2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.
•3. Have moderate to severe active disease despite MTX therapy defined as:
•a. More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
•b. 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 6 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 514
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•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 Remicade or SB2
•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-/bedbound).
•f. History of demyelinating disorders.

发起方