Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in FVC (% of the predicted value) in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.
研究概览
简要总结
Hypersensitivity pneumonitis (HP) presents with a highly variable clinical course, and Traditional treatment involves systemic corticosteroids in conjunction with strict avoidance of the offending antigen. However, a subset of patients with progressive disease remains unresponsive to conventional therapies. The objective of this study is to evaluate the therapeutic potential of Rituximab in individuals with refractory hypersensitivity pneumonitis who did not respond to conventional immunosuppressive therapy and antigen avoidance.
Assessing FVC at three intervals: six months prior to the initiation of Rituximab therapy (M-6), at the time of treatment initiation (M0), and six months afterward (M+6).
详细描述
The study will be conducted at the Chest Department, Faculty of Medicine, Cairo University during the period between June 2023 to January 2025. This study, which received approval from the Research Ethics Committee of Cairo University code (MD-180-2023), including 30 patients diagnosed with hypersensitivity pneumonitis at the Chest Department, Kasr Al Ainy Hospital, Cairo University.
Inclusion criteria:
- Age 18 years old and above.
- Patients with the diagnosis of chronic hypersensitivity pneumonitis, validated during a multidisciplinary team meeting with the criteria adapted from the CHEST guidelines 5, with decline in their FVC of greater than or equal 5% after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy (including corticoseroids and Azathioprine).
Exclusion criteria:
- Hypersensitivity to Rituximab.
- Severe heart failure.
- Moderate or severe pulmonary hypertension.
- Fibrotic hypersensitivity pneumonitis.
- Pregnancy.
- Active infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18 years old and above.
- •Patients with the diagnosis of chronic hypersensitivity pneumonitis, validated during a multidisciplinary team meeting with the criteria adapted from the CHEST guidelines, with decline in their FVC of greater than or equal 5% after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy (including corticosteroids and Azathioprine).
排除标准
- •Hypersensitivity to Rituximab.
- •Severe heart failure.
- •Moderate or severe pulmonary hypertension.
- •Fibrotic hypersensitivity pneumonitis.
- •Active infection.
研究组 & 干预措施
Rituximab in treatment refractory Hypersenstivity pneumonitis
Patients diagnosed with chronic Hypersensitivity Pneumonitis who have not responded to standard treatment including antigen avoidance and immunosuppressive therapy.
干预措施: Rituximab (Mabthera) (Drug)
结局指标
主要结局
Change in FVC (% of the predicted value) in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.
时间窗: From enrollment to the end of treatment and follow up of the clinical and functional status 18 months
Forced Vital Capacity (FVC) measured 6 months before rituximab therapy onset (M - 6), at rituximab onset (M0), and 6 months after rituximab intiation (M+6). The FVC% predicted change across treatment time points will be assessed to identify if Rituximab demonstrates potential as an effective treatment for individuals with hypersensitivity pneumonitis unresponsive to conventional therapy.
次要结局
- Change in 6MWD in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.(From the onset of Rituximab therapy (M0) till 6 months after the onset of therapy (M+6))
- Change in Dyspnea grade by mMRC scale in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.(From the onset of Rituximab therapy (M0) till 6 months after the onset of therapy (M+6))
研究者
Shereen Medhat Mohammed Elsayed Nassar
Shereen Medhat Mohammed Elsayed Nassar was the principle investigator
Cairo University