A randomized controlled trial To compare the efficacy of low dose versus standard dose rituximab in patients with systemic sclerosis interstitial lung disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare the change in forced vital capacity
研究概览
简要总结
Thisis an open label prospective randomised controlled trial. The study will becarried out on 30 consecutive consenting patients of SSc- ILD, with 15 in Rituximablow dose arm and 15 in the rituximab standard dose arm. Patients will be recruitedfrom outpatient department of internal medicine and rheumatology clinic of ourhospital. Patients will be followed up till 24 weeks on an open label basissubsequently. All patients fulfilling the classification criteria ofscleroderma (ACR/EULAR 2013) during the study period will be screened for the presenceof ILD. The study consists of two treatment arms. One arm will receive rituximab1g two dosage two weeks apart and the other arm will receive 500 mg two dosage2 weeks apart. We will be measuring the FVC predicted as the primary objectiveat 24 weeks . The secondary objectives will include functional outcomes likeSF-36 questionnaire, Mahlers Dyspnea Index, 6 minute Walk Distance, adverseeffects profile between the groups receiving low dose versus standard doserituximab, B cell depletion and serum immunoglobulins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with SSc as diagnosed by ACR
- •Duration of SSc for less than 10 years with onset defined as the appearance of the first non Raynauds symptom.
- •Consenting to participate in the study.
- •FVC of 40 percent or above the standard population, age matched.
- •HRCT chest suggestive of ILD (more than 10 percent of lung parenchyma).
排除标准
- •Clinically significant abnormality on chest X-ray or HRCT other than ILD changes (for example lung mass, effusion).
- •Pregnant or lactating females.
- •Severe pulmonary arterial hypertension (mPAP more than 55mmHg) requiring drug therapy.
- •Active infection.
- •Active myositis.
- •Prior use of rituximab in the last six months.
- •Positive for Hepatitis B surface antigen or Anti Hepatitis C virus antibody before the baseline visit.
- •Serum creatinine more than 2 mg/dl.
- •Serum ALT or AST more than 2 times ULN.
- •Active malignancy or history of malignancy in the last 5 years.
结局指标
主要结局
To compare the change in forced vital capacity
时间窗: 0 and 24 weeks
(FVC) (%) in subjects with
时间窗: 0 and 24 weeks
systemic sclerosis- Interstitial lung
时间窗: 0 and 24 weeks
disease(SSc-ILD) when treated with Rituximab Standard Dose versus Low dose Rituximab
时间窗: 0 and 24 weeks
次要结局
- 1.Change in modified Rodnan score (mRSS) at 24 weeks 2. Absolute change from baseline in FVC in litres at 24 weeks 3. Change in 6-minute walking distance at 24 weeks 4. To compare the change in Quality of Life (QoL) scores by Medical Outcomes Short Form (SF-36) and dyspnea scores by Mahler Dyspnea index at 24 weeks 5. All-cause mortality at 24 weeks 6. Incidence of adverse effects between the two groups 7. Peripheral B Cell depletion in standard dose versus low dose rituximab assessed by flowcytometry 8. Immunoglobulin profile pre and post treatment in standard dose versus low dose rituximab 9. Change in disease activity as assessed by 18F-FDG PET CT in standard dose versus low dose rituximab. 10. Difference in the cost incurred in the two arms based on Markov model(0 and 24 weeks)