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Anti-CD20 Antibodies for Treatment of SLE-PAH

NOT_RECRUITINGPhase 4Sponsored by Chinese SLE Treatment And Research Group
No longer actively recruiting
PhasePhase 4
SponsorChinese SLE Treatment And Research Group
Started2023-05-25
Est. completion2025-03
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05828147

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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.

Conditions3

LupusPulmonary Arterial HypertensionSystemic Lupus Erythematosus

Interventions1

Rituximab

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