Rituxmab Versus IL-6 in Treating ILD

Sponsor
Assiut University
Study ID
NCT05963048
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    IV infusion 1000 mg
  • IL6 inhibitor — DRUG
    6 mg/kg I V infusion monthly

Study Details

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

Key Dates

Start date
Dec 1, 2021
Status verified
Nov 2023
Primary completion
Dec 30, 2022
Completion
Jun 1, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituxmab
    1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
  • Experimental: IL-6 inhibitor
    6 mg/kg IV infusion every month not exceed 600 mg for 1 year

Primary Outcome Measure

forced vital capacity [ Time Frame: 6 months ]

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