Interstitial Lung Disease, Scleroderma
Conditions
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.
Interventions
DRUGRituximab
IV infusion 1000 mg
DRUGIL6 inhibitor
6 mg/kg I V infusion monthly
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
participant and outcome assrssor
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* active ILD scleroderma
Exclusion criteria
* abnormal liver enzymes renal impairment neutropenia \<1000 cells/mm3 thrombocytopenia \< 50,000 cells/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| forced vital capacity | 6 months | pulmonary function test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| computed tomography chest | 1 year | imaging |
| modified rodnan skin score | 6 months | skin score |
Countries
Egypt
Outcome results
None listed