风湿学聚焦临床研究
在炎性关节炎、系统性自身免疫疾病和结缔组织疾病方面提供全面的风湿病学试验支持——在复合反应终点和免疫原性评估方面具有专长。
自身免疫和炎症研究专业知识
Rheumatic diseases represent a rapidly evolving therapeutic area, driven by advances in biologic therapies, targeted synthetic DMARDs, and emerging cell therapies. Omega CRO provides comprehensive support for rheumatology clinical trials, combining deep therapeutic expertise with specialized laboratory capabilities through the Omega ecosystem.
Our experience encompasses the full spectrum of inflammatory and autoimmune rheumatic diseases. We understand the complexities of composite response criteria (ACR20/50/70, DAS28, PASI), the importance of immunogenicity testing for biologics, and the need for sensitive imaging modalities to detect subclinical disease activity.
风湿病学适应症
炎症性关节炎
- 类风湿关节炎（RA）
- 银屑病关节炎（PsA）
- 中轴型脊柱关节炎（AS/非影像学axSpA）
- 幼年特发性关节炎（JIA）
系统性自身免疫
- 系统性红斑狼疮（SLE）
- 系统性硬化症（硬皮病）
- 干燥综合征
- ANCA相关性血管炎
新兴领域
- 银屑病（与皮肤病学交叉）
- 化脓性汗腺炎
- IgA肾病
- 骨关节炎和骨骼健康
复合终点和免疫原性
复合应答标准
- 类风湿关节炎ACR20/50/70应答标准
- 疾病活动度评估：DAS28、CDAI、SDAI
- 中轴型脊柱关节炎ASAS应答标准
- SLEDAI、BICLA、SRI-4/6狼疮评估
- 集中化关节计数与影像审查
免疫原性和自身抗体检测
- 基于ELISA的ADA（抗药物抗体）筛查和确认
- 基于细胞的中和抗体（NAb）检测
- 类风湿因子（RF）与抗CCP抗体检测
- ANA、抗dsDNA、抗Sm抗体、补体C3/C4
- ANCA（MPO/PR3）和冷球蛋白检测
生物制剂、生物类似药和靶向治疗
在风湿病学试验中使用的所有主要治疗类别方面拥有丰富经验。
Omega生态系统中的应用场景
Omega生态系统如何支持风湿病学研究——从免疫原性检测到自身抗体分析和关节影像协调。
HelixLab
Inflammatory & Safety Panels
CRP (high-sensitivity), ESR, complement C3/C4, serum immunoglobulin levels, comprehensive safety panels, and drug trough level monitoring for biologic and JAK inhibitor trials.
Omega Genetics
HLA Typing & Risk Variants
HLA-B27 for axial spondyloarthritis stratification; HLA-DRB1 shared epitope for RA prognosis; PTPN22, STAT4, and IRF5 variants informing autoimmune disease patient selection.
Omega生物样本库
Serum & Synovial Fluid Archive
Serial serum and synovial fluid (where applicable) biobanking at -80\u00b0C for retrospective biomarker analysis, ADA re-testing, and translational immunology research.
Omega Care
Remote PRO & Joint Counts
Home-based DAS28, HAQ-DI, and pain NRS capture via mobile platform; wearable activity monitoring for RA and PsA patients; telemedicine joint assessment coordination.
Omega Bio
ADA & NAb Assay Kits
Kit-based ELISA harmonization for anti-drug antibody (ADA) screening and confirmation; cell-based neutralizing antibody (NAb) assay standardization across multi-center biologic trials.
动物设施
Arthritis & Lupus Models
Collagen-induced arthritis (CIA) models, adjuvant-induced arthritis, and NZB/W F1 lupus models for preclinical evaluation of biologics, JAK inhibitors, and emerging cell therapies.