跳至主要内容
临床试验/2023-504045-31-00
2023-504045-31-00已完成2 期

A Phase 2a Multicenter, Randomized, Double Blind, Parallel-group, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Subjects with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)

Janssen - Cilag International10 个研究点 分布在 3 个国家目标入组 55 人开始时间: 2023年10月9日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
55
试验地点
10
主要终点
Change from baseline in DAS28-CRP at Week 12

研究概览

简要总结

To evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy in participants with moderately to severely active RA despite ≥1 advanced therapy (bDMARDs or tsDMARDs).

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • 18 to 75 years of age, inclusive
  • Medically stable on the basis of clinical laboratory tests performed at screening
  • Diagnosis of RA and meeting the 2010 ACR/ EULAR Criteria for RA for at least 12 weeks before screening
  • Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline
  • Is positive for ACPA or RF by the central laboratory at the time of screening

排除标准

  • Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except RA), psychiatric, or metabolic disturbances, which are detected at screening assessments (ie, laboratory testing, physical examination, vital signs) or reported by the participant
  • Has other inflammatory diseases that might confound the evaluation of benefit in this study, including but not limited to Crohn’s disease, ulcerative colitis, interstitial lung disease, ankylosing spondylitis, psoriatic arthritis, primary Sjogren’s syndrome, SLE, and Lyme disease
  • Has a history of any clinically significant adverse reaction to therapeutic proteins (eg, mABs), including, but not limited to, allergic reactions or severe immediate hypersensitivity reactions, such as anaphylaxis
  • Allergies, hypersensitivity, or intolerance to investigational medicinal products
  • Has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure

研究组 & 干预措施

-

Auxiliary

Participants receiving -

干预措施: - (Drug)

结局指标

主要结局

Change from baseline in DAS28-CRP at Week 12

Change from baseline in DAS28-CRP at Week 12

次要结局

未报告次要终点

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

CTIS Point of Contact

Scientific

Janssen - Cilag International

研究点 (10)

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