Rituxmab Versus IL-6 in Treating ILD
- Conditions
- SclerodermaInterstitial Lung Disease
- Interventions
- Drug: IL6 inhibitor
- Registration Number
- NCT05963048
- Lead Sponsor
- Assiut University
- Brief Summary
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test
- Detailed Description
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- active ILD scleroderma
- abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IL-6 inhibitor IL6 inhibitor 6 mg/kg IV infusion every month not exceed 600 mg for 1 year Rituxmab Rituximab 1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
- Primary Outcome Measures
Name Time Method forced vital capacity 6 months pulmonary function test
- Secondary Outcome Measures
Name Time Method computed tomography chest 1 year imaging
modified rodnan skin score 6 months skin score
Trial Locations
- Locations (1)
Manal Hassanien
🇪🇬Assiut, Yes, Egypt