Rituxmab Versus IL-6 in Treating ILD

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Scleroderma; Interstitial Lung Disease

Treatments: Drug: IL6 inhibitor; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT05963048

Scleroderma

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• active ILD scleroderma

Exclusion criteria

• abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Rituxmab

Experimental group

Description:

1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year

Treatment:

Drug: Rituximab

IL-6 inhibitor

Experimental group

Description:

6 mg/kg IV infusion every month not exceed 600 mg for 1 year

Treatment:

Drug: IL6 inhibitor