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

A

Assiut University

Status and phase

Unknown
Phase 3

Conditions

Systemic Lupus Erythematosus
Autoimmune Hemolytic Anemia

Treatments

Drug: Mycophenolate Mofetil 500mg
Drug: Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT05057481
17300600

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

MMF arm
Active Comparator group
Treatment:
Drug: Mycophenolate Mofetil 500mg
Rituximab arm
Active Comparator group
Treatment:
Drug: Rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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