Systemic Lupus Erythematosus Clinical Trial
Official title:
Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Verified date | October 2021 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine, Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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 |
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