Rituxmab Versus IL-6 in Treating ILD

NCT ID: NCT05963048

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-06-01

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.

Conditions

Interstitial Lung Disease; Scleroderma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rituxmab

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

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

IV infusion 1000 mg

IL-6 inhibitor

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

Group Type: EXPERIMENTAL

IL6 inhibitor

Intervention Type: DRUG

6 mg/kg I V infusion monthly

Interventions

Rituximab

IV infusion 1000 mg

Intervention Type: DRUG

IL6 inhibitor

6 mg/kg I V infusion monthly

Intervention Type: DRUG

Other Intervention Names

Rituxan; Actemra

Eligibility Criteria

Inclusion Criteria

• active ILD scleroderma

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Manal Hassanien

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal Hassanien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Manal Hassanien

Asyut, Yes, Egypt

Countries

Egypt

Other Identifiers

Scleroderma

Identifier Type: -

Identifier Source: org_study_id