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

Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05057481

Enrollment

Registered

2021-09-27

Start date

2021-09-15

Completion date

2023-01-15

Last updated

2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus

Keywords

autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil

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.

Interventions

DRUGMycophenolate Mofetil 500mg

MMF 2gram/day orally for 12 weeks

DRUGRituximab

375 mg/m2 of rituximab given intravenously weekly for 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
complete response (CR) proportion	12 weeks	CR defined as hemoglobin \> 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
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.
rate of Adverse events	12 weeks	rate of occurrence of adverse events of the both drugs

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026