Back to resultsRituxmab Versus IL-6 in Treating ILD
Primary Purpose
Interstitial Lung Disease, Scleroderma
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Rituximab
IL6 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease
Eligibility Criteria
Inclusion Criteria: active ILD scleroderma Exclusion Criteria: abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
Sites / Locations
- Manal Hassanien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rituxmab
IL-6 inhibitor
Arm Description
1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
6 mg/kg IV infusion every month not exceed 600 mg for 1 year
Outcomes
Primary Outcome Measures
forced vital capacity
pulmonary function test
Secondary Outcome Measures
CT chest
imaging
modified rodnan skin score
skin score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05963048
Brief Title
Rituxmab Versus IL-6 in Treating ILD
Official Title
Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Scleroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
participant and outcome assrssor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituxmab
Arm Type
Experimental
Arm Description
1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
Arm Title
IL-6 inhibitor
Arm Type
Experimental
Arm Description
6 mg/kg IV infusion every month not exceed 600 mg for 1 year
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
IV infusion 1000 mg
Intervention Type
Drug
Intervention Name(s)
IL6 inhibitor
Other Intervention Name(s)
Actemra
Intervention Description
6 mg/kg I V infusion monthly
Primary Outcome Measure Information:
Title
forced vital capacity
Description
pulmonary function test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CT chest
Description
imaging
Time Frame
1 year
Title
modified rodnan skin score
Description
skin score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
active ILD scleroderma
Exclusion Criteria:
abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Yes
ZIP/Postal Code
7111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after finishing
IPD Sharing Time Frame
one year
IPD Sharing Access Criteria
after finishing the study
Learn more about this trial
Rituxmab Versus IL-6 in Treating ILD
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