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Rituxmab Versus IL-6 in Treating ILD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05963048
Recruitment Status : Completed
First Posted : July 27, 2023
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Scleroderma Drug: Rituximab Drug: IL6 inhibitor Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: participant and outcome assrssor
Primary Purpose: Treatment
Official Title: Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : December 30, 2022
Actual Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rituxmab
1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
 Drug: Rituximab
IV infusion 1000 mg
Other Name: Rituxan
Experimental: IL-6 inhibitor
6 mg/kg IV infusion every month not exceed 600 mg for 1 year
 Drug: IL6 inhibitor
6 mg/kg I V infusion monthly
Other Name: Actemra


Outcome Measures
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Primary Outcome Measures :
  1. forced vital capacity [ Time Frame: 6 months ]
    pulmonary function test


Secondary Outcome Measures :
  1. computed tomography chest [ Time Frame: 1 year ]
    imaging

  2. modified rodnan skin score [ Time Frame: 6 months ]
    skin score


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • active ILD scleroderma

Exclusion Criteria:

  • abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963048


Locations
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Egypt
Manal Hassanien
Assiut, Yes, Egypt, 7111
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Manal Hassanien, MD Assiut University
More Information
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Responsible Party: Manal Hassanien, Associate Professor, Assiut University
ClinicalTrials.gov Identifier: NCT05963048    
Other Study ID Numbers: Scleroderma
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after finishing
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: one year
Access Criteria: after finishing the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
 Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents