Dissecting the Role of B Lymphocytes in the Loss of Immunological Tolerance and Disease Resolution Through JAK Signaling In Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peripheral blood and synovial tissue B lymphocyte atlas
研究概览
简要总结
The study will reveal the transcriptomic signature linked to the aberrant activation of B lymphocytes in RA identifying novel molecular potential targets for inflammation resolution and immune tolerance promotion. The combination with B lymphocytes phenotyping will dissect the impact of the identified genes on B lymphocyte maturation and activation in RA. Moreover, in vitro study on B lymphocyte cultures using selective JAK1 inhibition will reveal, at deeper level, its transcriptomic effect on RA B lymphocytes activation profile and phenotype, providing the discovery of new biomarkers of the loss of immunological tolerance, active disease and long lasting disease remission.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent. Before any study procedures are performed,subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of trained study personnel.
- •Patients fulfilling classification criteria for Rheumatoid Arthritis (2010 ACR/EULARclassification criteria)
- •Age: 18-70 years
- •For preclinical cohort: Individuals with positivity for ACPA or IgM/IgA RF without clinical signs of arthritis, whose positivity is not related to other concomitant pathologic conditions.
- •For naive to treatment cohort: RA patients without previous exposure to conventional DMARDs or biologic/targeted synthetic-DMARDs.
- •For resistant to treatment cohort: RA patients with failure to previous conventionalDMARDs for inadequate response or side effects.
- •For remission RA cohort: RA patients in sustained clinical and ultrasound remission as stated in section 3.3.
- •For healthy control cohort: Healthy donors will be aged from 18 to 70 years.
排除标准
- •Severe and uncontrolled infections such as sepsis and opportunistic infections.
- •Patients who are currently included in any interventional clinical trial in RA.
- •RA patients in therapy with other biologics.
- •Healthy donors receiving anti-inflammatory drugs
结局指标
主要结局
Peripheral blood and synovial tissue B lymphocyte atlas
时间窗: 24 months
次要结局
未报告次要终点
研究者
Gremese Elisa
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS