NL-OMON52687已完成2 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis. - IM014029
Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- 18 至 99（—）
入选标准
- •Sub-Protocol for Systemic Lupus Erythematosus (SLE):
- •- Active SLE as defined by the Systemic Lupus Erythematosus
- •International Collaborating Clinics (SLICC) classification.
- •- Diagnosed with SLE more than 24 weeks before screening visit.
- •Sub-Protocol for primary Sjögren's Syndrome (pSS):
- •- Moderate to severe pSS, meeting ACR-EULAR classification criteria.
- •Sub-Protocol for active Rheumatoid Arthritis (RA):
- •- Moderate to severe adult-onset RA.
- •- ACR global functional status class I to III.
- •For all sub-studies:
- •- Women and men must agree to follow instructions for methods of
- •contraception.
- •Please, be referred to the Protocol document for a complete list of
- •Inclusion citeria.
排除标准
- •Sub-Protocol for Systemic Lupus Erythematosus (SLE):
- •- Certain other autoimmune diseases and overlap syndromes.
- •Sub-Protocol for primary Sjögren's Syndrome (pSS):
- •- Certain other immune-mediated diseases, active fibromyalgia, or other
- •medical conditions.
- •Sub-Protocol for Rheumatoid Arthritis (RA):
- •- Diagnosis with juvenile arthritis or idiopathic arthritis before age 16.
- •For all sub-studies:
- •- History of any significant drug allergy
- •- Active infection, significant concurrent medical condition, or clinically
- •significant abnormalities
- •Please, be referred to the Protocol document for a complete list of
- •Exclusion citeria.
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