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

NCT ID: NCT05057481

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-01-15

Brief Summary

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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

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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.

Conditions

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Autoimmune Hemolytic Anemia Systemic Lupus Erythematosus

Keywords

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autoimmune hemolytic anemia systemic lupus erythematosus mycophenolate mofetil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MMF arm

Group Type ACTIVE_COMPARATOR

Mycophenolate Mofetil 500mg

Intervention Type DRUG

MMF 2gram/day orally for 12 weeks

Rituximab arm

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

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

Interventions

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Mycophenolate Mofetil 500mg

MMF 2gram/day orally for 12 weeks

Intervention Type DRUG

Rituximab

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Eman Mohammed Ibrahem Kamel

lecturer in internal medicine department of faculty of medicine,Assiut university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of medicine, Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17300600

Identifier Type: -

Identifier Source: org_study_id