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OpenTrials
Completed

NCT Number: NCT05963048

Rituxmab Versus IL-6 in Treating ILD

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

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Key information

Conditions

Interstitial Lung Disease Connective Tissue Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Manal Hassanien

Asyut, Yes, 7111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • active ILD scleroderma

Exclusion criteria

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

Treatment and study plan

Rituximab

Drug

IV infusion 1000 mg

Other names: Rituxan

IL6 inhibitor

Drug

6 mg/kg I V infusion monthly

Other names: Actemra

Primary outcomes

  1. forced vital capacity

    Time frame: 6 months

    pulmonary function test

Secondary outcomes

  1. computed tomography chest

    Time frame: 1 year

    imaging

  2. modified rodnan skin score

    Time frame: 6 months

    skin score

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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