Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

Phase 3

• Conditions: Systemic Lupus Erythematosus; Autoimmune Hemolytic Anemia
• Interventions: Drug: Mycophenolate Mofetil 500mg; Drug: Rituximab

• Registration Number: NCT05057481
• Lead Sponsor: Assiut University

Brief Summary

There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Detailed Description

There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, the investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of erythematosus (SLE) according to The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines.
• secondary autoimmune hemolytic anemia (AIHA) that does not respond properly to corticosteroid or when the patients are intolerant to treatment, or refuse standard treatment.

Exclusion Criteria

• Pregnant or breastfeeding women.
• any contraindication of the used drugs.
• any known hypersensitivity of the used drugs.
• congenital hemolytic anemia.
• chronic renal failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMF arm	Mycophenolate Mofetil 500mg	-
Rituximab arm	Rituximab	-

Primary Outcome Measures

Name	Time	Method
complete response (CR) proportion	12 weeks	CR defined as hemoglobin \> 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
rate of Adverse events	12 weeks	rate of occurrence of adverse events of the both drugs
partial response (PR) proportion	12 weeks	PR defined as hemoglobin 10-12 g/dL or at least ≥ 2 g/dL increase from baseline not attributed to transfusion effect and the normalization of hemolytic markers.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Chronic Illness	12 weeks	Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire

Trial Locations

Locations (1)

faculty of medicine, Assiut university; 🇪🇬 Assiut, Egypt