Back to resultsReappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Primary Purpose
Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Mycophenolate Mofetil 500mg
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hemolytic Anemia focused on measuring autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil
Eligibility Criteria
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.
Sites / Locations
- faculty of medicine, Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MMF arm
Rituximab arm
Arm Description
Outcomes
Primary Outcome Measures
complete response (CR) proportion
CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
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.
rate of Adverse events
rate of occurrence of adverse events of the both drugs
Secondary Outcome Measures
Functional Assessment of Chronic Illness
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05057481
Brief Title
Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Official Title
Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus
Keywords
autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MMF arm
Arm Type
Active Comparator
Arm Title
Rituximab arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil 500mg
Intervention Description
MMF 2gram/day orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 of rituximab given intravenously weekly for 4 weeks.
Primary Outcome Measure Information:
Title
complete response (CR) proportion
Description
CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
Time Frame
12 weeks
Title
partial response (PR) proportion
Description
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.
Time Frame
12 weeks
Title
rate of Adverse events
Description
rate of occurrence of adverse events of the both drugs
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Chronic Illness
Description
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
faculty of medicine, Assiut university
City
Assiut
ZIP/Postal Code
17111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
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