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

NCT05057481 | Unknown Phase 3

• 1 other identifier: 17300600
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hemolytic Anemia; Systemic Lupus Erythematosus

Keywords

autoimmune hemolytic anemia; systemic lupus erythematosus; mycophenolate mofetil

Outcome Measures

Primary Outcomes (3)

• complete response (CR) proportion

  CR defined as hemoglobin \> 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.

  12 weeks

• 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

• rate of Adverse events

  rate of occurrence of adverse events of the both drugs

  12 weeks

Secondary Outcomes (1)

• Functional Assessment of Chronic Illness

  12 weeks

Study Arms (2)

MMF arm

ACTIVE COMPARATOR

Drug: Mycophenolate Mofetil 500mg

Rituximab arm

ACTIVE COMPARATOR

Drug: Rituximab

Interventions

Mycophenolate Mofetil 500mg DRUG

MMF 2gram/day orally for 12 weeks

MMF arm

Rituximab DRUG

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

Rituximab arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• any contraindication of the used drugs.
• any known hypersensitivity of the used drugs.
• congenital hemolytic anemia.
• chronic renal failure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

faculty of medicine, Assiut university

Asyut, 17111, Egypt

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune; Lupus Erythematosus, Systemic

Interventions

Mycophenolic Acid; Rituximab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in internal medicine department of faculty of medicine,Assiut university

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: September 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 15, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

EG (1)