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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05057481
• Other study ID #: 17300600
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Hemolysis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of medicine, Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response (CR) proportion	CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.	12 weeks
Primary	partial response (PR) proportion	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.	12 weeks
Primary	rate of Adverse events	rate of occurrence of adverse events of the both drugs	12 weeks
Secondary	Functional Assessment of Chronic Illness	Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire	12 weeks