Autoimmune Hemolytic AnemiaPhase 3NCT05057481
Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
A Phase 3 study testing Mycophenolate Mofetil 500mg and Rituximab in people with Autoimmune Hemolytic Anemia and Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus
- What is being tested?
- Mycophenolate Mofetil 500mg and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 15 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding women.
- any contraindication of the used drugs.
- any known hypersensitivity of the used drugs.
- congenital hemolytic anemia.
- chronic renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
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.
Read the 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.
- Being tested
- Mycophenolate Mofetil 500mg, Rituximab
- Keywords
- autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil 500mgDrug
MMF 2gram/day orally for 12 weeks
RituximabDrug
375 mg/m2 of rituximab given intravenously weekly for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MMF arm | Active comparator | Not described Receives: Drug: Mycophenolate Mofetil 500mg |
| Rituximab arm | Active comparator | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR) proportion
CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
Measured: 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.
Measured: 12 weeks
rate of Adverse events
rate of occurrence of adverse events of the both drugs
Measured: 12 weeks
Secondary outcomes (1)
Functional Assessment of Chronic Illness
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Ibrahem Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057481
- Sponsor's protocol ID
- 17300600
- Status last verified
- Oct 2021
- First submitted
- 16 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05057481
- Acronym / sponsor ID
- 17300600
- Keywords
- autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMF arm | Active comparator | Drug: Mycophenolate Mofetil 500mg |
| Rituximab arm | Active comparator | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- any contraindication of the used drugs.
- any known hypersensitivity of the used drugs.
- congenital hemolytic anemia.
- chronic renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate Mofetil 500mgMMF 2gram/day orally for 12 weeks | Drug | MMF arm |
| Rituximab375 mg/m2 of rituximab given intravenously weekly for 4 weeks. | Drug | Rituximab arm |
Primary outcome
complete response (CR) proportion
Time frame: 12 weeks
CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
partial response (PR) proportion
Time frame: 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.
rate of Adverse events
Time frame: 12 weeks
rate of occurrence of adverse events of the both drugs
1 secondary outcome
Functional Assessment of Chronic Illness
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mycophenolate Mofetil 500mg and Rituximab in people with Autoimmune Hemolytic Anemia and Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) proportion (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.