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

• Sponsor: Assiut University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05057481
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Hemolytic Anemia; Systemic Lupus Erythematosus	Drug: Mycophenolate Mofetil 500mg; Drug: Rituximab	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
• Actual Study Start Date: Sep 15, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MMF arm	Drug: Mycophenolate Mofetil 500mg; MMF 2gram/day orally for 12 weeks
Active Comparator: Rituximab arm	Drug: Rituximab; 375 mg/m2 of rituximab given intravenously weekly for 4 weeks.

Outcome Measures

Primary Outcome Measures

1. complete response (CR) proportion [12 weeks]

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

2. partial response (PR) proportion [12 weeks]

   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.

3. rate of Adverse events [12 weeks]

   rate of occurrence of adverse events of the both drugs

Secondary Outcome Measures

1. Functional Assessment of Chronic Illness [12 weeks]

   Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine, Assiut university	Assiut		Egypt	17111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Mohammed Ibrahem Kamel, lecturer in internal medicine department of faculty of medicine,Assiut university, Assiut University
• ClinicalTrials.gov Identifier: NCT05057481
• Other Study ID Numbers: 17300600
• First Posted: Sep 27, 2021
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Eman Mohammed Ibrahem Kamel, lecturer in internal medicine department of faculty of medicine,Assiut university, Assiut University: autoimmune hemolytic anemia; systemic lupus erythematosus; mycophenolate mofetil
• Additional relevant MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Lupus Erythematosus, Systemic; Hemolysis; Mycophenolic Acid; Rituximab

Study Results

No Results Posted as of Oct 27, 2021