A Phase 3 interventional study of Mycophenolate Mofetil 500mg and Rituximab in Autoimmune Hemolytic Anemia and Systemic Lupus Erythematosus, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's planned enrollment of 30 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Mycophenolate Mofetil 500mg
Drug: Rituximab
MMF 2gram/day orally for 12 weeks
375 mg/m2 of rituximab given intravenously weekly for 4 weeks.
complete response (CR) proportion
CR defined as hemoglobin \> 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
Time frame: 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.
Time frame: 12 weeks
rate of Adverse events
rate of occurrence of adverse events of the both drugs
Time frame: 12 weeks
Functional Assessment of Chronic Illness
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire
Time frame: 12 weeks
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Assiut University