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Rituxmab Versus IL-6 in Treating ILD

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05963048
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Dec 1, 2021
Actual Primary Completion Date :
Dec 30, 2022
Actual Study Completion Date :
Jun 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Actemra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. forced vital capacity [6 months]

      pulmonary function test

    Secondary Outcome Measures

    1. CT chest [1 year]

      imaging

    2. modified rodnan skin score [6 months]

      skin score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • active ILD scleroderma
    Exclusion Criteria:
    • abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manal Hassanien Assiut Yes Egypt 7111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Manal Hassanien, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manal Hassanien, Associate Professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05963048
    Other Study ID Numbers:
    • Scleroderma
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Lung Diseases
    Lung Diseases, Interstitial
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Rituximab

    Study Results

    No Results Posted as of Jul 27, 2023