NCT03882008已完成4 期
Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14
研究概览
简要总结
The primary objective of this study is to evaluate if baseline levels of T cell associated biomarkers predict efficacy of abatacept during 24 weeks of treatment in patients with moderate to severe active Rheumatoid Arthritis (RA) who have had an inadequate response to conventional disease modifying anti-rheumatic drugs (cDMARDs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or non-pregnant, non-nursing female
- •Age 18 years or greater
- •Body weight less than or equal to 120 kg
- •Classification of Rheumatoid Arthritis according to the 1987 ACR criteria or 2010 ACR/EULAR criteria
- •Symptoms of Rheumatoid Arthritis present for at least 3 months and less that 10 years prior to Screening.
- •Clinical Disease Activity Index (CDAI) greater than or equal to 16, corresponding to moderate to severe disease activity.
- •Patients taking oral DMARDs must be on stable doses of DMARDs for at least 4 weeks prior to Abatacept initiation
- •Treatment within the past year with either methotrexate, leflunomide, hydroxychloroquine and/or sulfasalazine for greater than or equal to 8 weeks.
- •Patients who have received one prior Tumor necrosis factor (TNF) inhibitor must have discontinued etanercept, infliximab, adalimumab, certolizumab, or golimumab for at least 6 months prior to screening.
- •Patients taking oral corticosteroids, the dose must be less than or equal to 5mg per day (prednisone or equivalent)
- •Females of child bearing potential and males with female partners of child bearing potential may participate in this study only if using a reliable means of contraception
排除标准
- •Previous treatment with Abatacept (Orencia)
- •Previous treatment with rituximab, tocilizumab, tofacitinib, sarilumab, or anakinra
- •Previous treatment with IV immunoglobulin, plasmapheresis, or alkylating agents such as cyclophosphamide
- •Intraarticular or parenteral corticosteroids within 4 weeks of screening
- •Rheumatic autoimmune disease other than Rheumatoid Arthritis, including Systemic Lupus Erythematosus, primary Sjogren syndrome, spondyloarthritis, systemic sclerosis, dermatomyositis, mixed connective tissue disease, or vasculitis
- •Non-rheumatic auto-immune disease including inflammatory bowel disease, psoriasis, multiple sclerosis
- •Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, latent tuberculosis (TB) (TB not adequately treated)
- •Primary or secondary immunodeficiency
- •Current, uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease
- •History of malignancy within 10 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma
- •History of alcohol, drug, or chemical abuse within 1 year prior to screening
- •Laboratory exclusion criteria at screening including:
- •estimated glomerular filtration rate (eGFR) <30ml/min
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >1.5 times upper limit of normal
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
- •Immunization with a live/attenuated vaccine within 4 weeks prior to screening
- •Pregnant or nursing women, or women of child bearing potential who plan to become pregnant prior to 14 weeks after the last dose of abatacept treatment
- •Patients of reproductive potential not willing to use an effective method of contraception
- •Prisoners, or subjects who are compulsory detained
研究组 & 干预措施
Abatacept
Experimental
Abatacept 125mg subcutaneous injection weekly for 24 weeks
干预措施: Abatacept (Drug)
结局指标
主要结局
Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14
时间窗: 14 Weeks
Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
次要结局
- Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24(Week 24)
- Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24(24 Weeks)
- Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24(Week 24)
- Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24(Week 24)
研究者
Kwanghoon (Bobby) Han
Assistant Professor, School of Medicine: Department of Medicine: Rheumatology
University of Washington
研究点 (1)
Loading locations...
相似试验
终止
不适用
A Biomarker Screening Protocol for Participants With Solid TumorsTriple Negative Breast CancerNon Small Cell Lung CancerNon Small Cell Lung Cancer MetastaticNon-Small Cell Carcinoma of Lung, TNM Stage 4Advanced Lung CarcinomaNSCLC, RecurrentNSCLC Stage IVRelapsed CancerRelapse/RecurrenceRecurrent Breast CancerRecurrent NSCLCPlatinum-resistant Ovarian CancerFallopian Tube CancerEndometrial CancerEndometrioid TumorHigh Grade Serous CarcinomaOvarian Epithelial CancerOvarian CancerNon-small Cell Lung CancerNSCLCAdvanced Breast CancerPrimary Peritoneal CarcinomaNCT05891197Lyell Immunopharma, Inc.10
终止
1 期
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/LeukemiaCancerLymphomaLeukemiaNCT00105313MedImmune LLC80
终止
1 期
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast CancerBreast CancerNCT00754312Syndax Pharmaceuticals1
已完成
1 期
Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected AdultsHIV InfectionsNCT00486408National Institute of Allergy and Infectious Diseases (NIAID)35
Unknown
早期 1 期
Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast CancerBreast Neoplasm FemaleStage I Breast CancerStage II Breast CancerHormone Receptor Negative NeoplasmHormone Receptor Positive TumorNCT03691311Institut Català d'Oncologia60