JPRN-jRCT2080222455未知3 期
A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 50
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
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •(1) RA patients diagnosed according to the American College of Rheumatology (ACR) criteria (1987).
- •(2) Patients with inadequate response to tocilizumab subcutaneous injection 162 mg every other week.
排除标准
- •(1) Patients who have been treated with any of the following within 4 weeks prior to the screening test.
- •DMARDs or immunosuppressants where the dosage regimen was changed.
- •(2) Patients for whom the following criteria apply at the screening test.
- •1) WBC count : Less than 3500/micro L
- •2) Neutrophil count : Less than 1000/micro L
- •3) Lymphocyte count : Less than 500/micro L
- •4) Platelet count : Less than 100,000 micro
研究者
相似试验
进行中(未招募)
1 期
A Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated Follicular LymphomaMedDRA version: 21.1Level: PTClassification code 10016910Term: Follicle centre lymphoma, follicular grade I, II, III stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Follicular LymphomaEUCTR2018-004223-36-RODr. Reddy’s Laboratories S.A.284
进行中(未招募)
1 期
A Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated Follicular LymphomaFollicular LymphomaEUCTR2018-004223-36-ESDr. Reddy’s Laboratories S.A.284
进行中(未招募)
1 期
A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara in Patients with Moderate-to-Severe Plaque PsoriasisModerate-to-Severe Plaque PsoriasisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2019-004364-21-PLbioeq GmbH392
进行中(未招募)
1 期
A Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated Follicular LymphomaMedDRA version: 21.1Level: PTClassification code 10016910Term: Follicle centre lymphoma, follicular grade I, II, III stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Follicular LymphomaEUCTR2018-004223-36-GRDr. Reddy’s Laboratories S.A.312
进行中(未招募)
1 期
A Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated Follicular LymphomaFollicular LymphomaEUCTR2018-004223-36-BGDr. Reddy’s Laboratories S.A.284
