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

Sponsor
Assiut University
Study ID
NCT05057481
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mycophenolate Mofetil 500mg — DRUG
    MMF 2gram/day orally for 12 weeks
  • Rituximab — DRUG
    375 mg/m2 of rituximab given intravenously weekly for 4 weeks.

Study Details

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.

Key Dates

Start date
Sep 15, 2021
Status verified
Oct 2021
Primary completion
Dec 31, 2022
Completion
Jan 15, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MMF arm
  • Active Comparator: Rituximab arm

Primary Outcome Measure

complete response (CR) proportion [ Time Frame: 12 weeks ]

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