RecruitingPhase 4NCT05828147

Anti-CD20 Antibodies for Treatment of SLE-PAH

Efficacy and Mechanism of Anti-CD20 Antibodies in Systemic Lupus Erythematosus Associated Pulmonary Arterial Hypertension Based on Multi Omics Studies

Sponsor

Chinese SLE Treatment And Research Group

Enrollment

50 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension Systemic Lupus Erythematosus

Summary

This is a prospective, single-arm, single-center, explorative clinical trial to evaluate the effect of Rituximab on disease progression in subjects with SLE-PAH receiving concurrent stable-dose standard medical therapy. The study will focus on assessment of clinical response and safety measures longitudinally. In addition, the biomarker of treatment efficacy with Rituximab and pathogenic autoantibody response in this disease will be investigated.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether anti-CD20 antibody medications (a type of immune-suppressing biologic drug used in conditions like rheumatoid arthritis and lymphoma) can treat pulmonary arterial hypertension (high blood pressure in the lungs) caused by systemic lupus erythematosus (SLE), an autoimmune disease. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with both systemic lupus erythematosus (lupus) and pulmonary arterial hypertension related to lupus within the past 5 years - Your pulmonary hypertension is confirmed by a heart catheter test showing elevated pressures - You are classified as WHO functional class II, III, or IV for pulmonary hypertension - You have been on stable background PAH medication for at least 8 weeks **You may NOT be eligible if...** - You have received certain biologic immune-suppressing drugs within the past 4–8 weeks - Your lupus is causing life-threatening complications (e.g., severe neurological involvement, serious bleeding, or respiratory failure from lung hemorrhage) - You have an uncontrolled active infection - You have severe liver disease or very low heart pump function - Your blood counts or liver tests are significantly abnormal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

Rituximab will be administered as two IV infusions of 1000 mg each, given two weeks apart at Day 0 and Week 2. All subjects will receive 40 mg of prednisone orally the night before and morning of each infusion with diphenhydramine and acetaminophen orally thirty to sixty minutes prior to each infusion of rituximab. Subjects will remain on their baseline standard medical regimen.