CTRI/2019/02/017795尚未招募未知
A randomised controlled trial comparing the efficacy and safety of rituximab, intravenous cyclophosphamide pulse and mycophenolate mofetil in systemic sclerosis.
ICMR grant applied0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with a diagnosis of systemic sclerosis as per the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, irrespective of their gender, will be included in the study. They may have either diffuse cutaneous or limited cutaneous systemic sclerosis.
- •2. Age >=12 years
- •3. Patients with the following evidence of pulmonary involvement:
- •% predicted FVC <= 70% and/or
- •HRCT chest showing involvement of >= 20% of lung area with interstitial lung disease.
排除标准
- •1. Patients with overlap syndrome.
- •2. Diagnosis of clinically significant resting pulmonary hypertension requiring treatment diagnosed on echocardiography (defined as tricuspid regurgitation velocity >= 4m/s, eqivalent to estimated pulmonary artery systolic pressure of 64 mm Hg) while evaluation of the patient during study.
- •3. Evidence of uncontrolled congestive heart failure, unstable ischemic heart disease, history of pulmonary embolism, or cardiac arrhythmia requiring chronic anticoagulation.
- •4. FVC <= 15% at baseline.
- •5. Patients who cannot perform spirometry for evaluation of pulmonary function tests despite sufficient counselling about the procedure.
- •6. More than 50% area of lung showing fibrosis on HRCT chest at baseline.
- •7. Hematologic abnormality at screening including:
- •Leukopenia (white blood cells [WBC] < 4.0x103/µl).
- •Thrombocytopenia (platelet count < 150.0x103/µl).
- •Clinically significant anemia (hemoglobin < 7 g/dl).
- •Participants with an identified and correctable etiology will be eligible if repeat testing shows values greater than the above mentioned cut-off.
- •8. A diagnosis of chronic liver disease or abnormal baseline liver function tests (total bilirubin or liver enzymes, alanine aminotransferase and aspartate aminotransferase > 2.0 times the upper normal limit).
- •9. Serum creatinine >2.0mg/dl
- •10. Pregnancy and/or breast feeding
- •11. If of child bearing potential (a female participant < 55 years of age who has not been postmenopausal for >= 5 years or who has not had a hysterectomy and/or oophorectomy), failure to employ reliable means of contraception.
- •12. Prior use of oral or intravenous cyclophosphamide, MMF, azathioprine or other putative disease modifying medications in last 3 months (assessed at baseline).
- •13. Current use, or use within the 30 days prior to their baseline visit, of prednisone (or equivalent) in dose of 40 mg/day.
- •14. Active infection (Hepatitis B, Hepatitis C, tuberculosis, HIV) whose management would be compromised by immunosuppression.
研究者
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