EUCTR2019-002205-22-ES进行中（未招募）1 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.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
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
- •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 criteria.
- •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 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 criteria.
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