Anti-CD20 Antibodies for Treatment of SLE-PAH

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Apr 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Rituximab on patients who have both systemic lupus erythematosus (SLE) and pulmonary arterial hypertension (PAH). The goal is to see how well Rituximab can help slow down the progression of these conditions in people who are already receiving standard treatments. Researchers will also examine how safe the medication is and look for specific markers in the blood that might indicate how well the treatment is working.

To participate in this trial, individuals must be between 18 and 65 years old, have a confirmed diagnosis of SLE with PAH, and have been on stable doses of standard treatments for at least a month. Participants will be monitored over time to assess their response to the treatment and any side effects they may experience. It's important to note that certain health conditions, such as severe organ damage or ongoing infections, may prevent someone from joining the study. If you or a loved one is considering participation, this trial offers a chance to contribute to important research while receiving close medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject has provided written informed consent.
• • 2. Subject must be between the ages of 18 and 65, inclusive at the time of recruitment
• • 3. Clinical diagnosis of systemic lupus erythematosus. Diagnosis of SLE-PAH within the past 5 years, with a mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg, PAWP ≤15mmHg, mean PVR of \> 3 Wood units at entry.
• • 4. WHO Functional Class II, III, or IV.
• • 5. Subjects must have been treated with background medical therapy for PAH (prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators) for a minimum of 8 weeks and have been on stable dose(s) of those medical therapy(ies) for at least 4 weeks prior to randomization with no expectation of change for 24 weeks after randomization.
• Exclusion Criteria:
• • 1. Treatment with immunocompromising biologic agents (including, but not limited to TNF inhibitors, anakinra, abatacept, and tocilizumab) within 4 weeks prior to treatment initiation or treatment with infliximab within 8 weeks prior to treatment initiation.
• * 2. SLE combined with important organ damage endangers life:
• • 1. Neuropsychiatric lupus with high risk such as status epilepticus;
• • 2. Refractory thrombocytopenic purpura has a clear bleeding tendency;
• • 3. Pulmonary alveolar hemorrhage leads to respiratory failure;
• • 3. Uncontrolled infection;
• * 4. Severe organ dysfunction:
• • 1. Patients with moderate or severe liver function impairment (Child-Pugh grade B and C);
• • 2. Patients with left ventricular dysfunction (left ventricular ejection fraction\<45%);
• • 5. Other diseases are limited to completing a 6-minute walking test: angina pectoris, vascular, musculoskeletal lesions, etc
• • 6. Abnormal laboratory test: platelet\<100 × 109/L, or hemoglobin\<9 g/dL, or white blood cell count\<3 × 109/L, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal value, or total bilirubin and blood lipids greater than 2 times the upper limit of normal value
• • 7. Persistent hypotension, i.e. systolic blood pressure (SBP)\<90 mmHg
• • 8. PAH caused by any reason other than SLE: other rheumatic diseases (such as SSc, rheumatoid arthritis, dermatomyositis, etc.); Portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and poisons;
• • 9. Chronic hypoxic disease related pulmonary hypertension: moderate or severe obstructive pulmonary disease: FEV1\<55%; Moderate or severe restrictive pulmonary disease: TLC\<60%;
• • 10. Chronic thromboembolic pulmonary hypertension: Pulmonary ventilation/perfusion imaging indicates moderate to high suspicion of pulmonary thromboembolism;
• • 11. Existing infections or uncontrollable infections that require antibiotic or antiviral treatment;
• • 12. Women who are breastfeeding or pregnant or who plan to become pregnant during the study;
• • 13. History of malignant tumors in the past 5 years
• • 14. Mental, addictive, or other illnesses that restrict patients from providing informed consent or complying with research requirements;
• • 15. Any condition or treatment that the investigator believes puts the subject at an unacceptable risk as a test participant.