NCT00583557终止2 期
A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 155
- 试验地点
- 48
- 主要终点
- To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
研究概览
简要总结
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
详细描述
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed the LBRA01 trial.
- •Have achieved at least an ACR20 response at the end of LBRA
排除标准
- •Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA
- •Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA
- •Used prohibited medications during their participation in LBRA
- •These medications include the following:
- •Other investigational agents.
- •Biologic response modifiers
- •Cyclophosphamide.
- •Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
- •2 new DMARDs.
- •1 new DMARD plus high dose prednisone >10 mg/day.
研究组 & 干预措施
Belimumab
Experimental
干预措施: belimumab (Drug)
结局指标
主要结局
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
时间窗: Up to 5 years
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
次要结局
- The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).(up to 5 Years)
研究者
研究点 (48)
Loading locations...
相似试验
已完成
2 期
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02Systemic Lupus ErythematosusNCT00583362Human Genome Sciences Inc., a GSK Company298
撤回
2 期
A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 StudySubjects With NSCLC With an EGFR Activating MutationNCT03042013Astellas Pharma Global Development, Inc.
Unknown
不适用
Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)Crohn's DiseaseNCT02926300Kang Stem Biotech Co., Ltd.24
已完成
3 期
Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic DermatitisAtopic DermatitisNCT05142774Organon and Co728
已完成
2 期
An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)Thrombocythemia, EssentialPrimary MyelofibrosisNCT05223920Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)80