Refractory Anemia in Systemic Lupus ErythematosisNCT06210295
Anemia in Systemic Lupus Erythematosus Specially Refractory Type
An observational study of Refractory Anemia in Systemic Lupus Erythematosis, run by Assiut University.
Trial summary
Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Anemia in Systemic Lupus Erythematosis
- What is being tested?
- Laboratory investigtions
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 9 Jul 2024to 20 Dec 2024
- Phase
- Observational
- 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
Study population: Patient diagnosed as systemic lupus erythematosus with anemia aged more than 18 year old
Who may be able to join
- -Adult patients (≥18 years) satisfying 2019 EULAR/ACR classification for systemic lupus erythroematosis[24].
- Patients satisfying WHO criteria definition of anemia.
Who cannot join
- Mixed connective tissue disorders.
- Pregnancy .
About this study
Official title: What is Behind Anemia in Systemic Lupus Erythematosus With Special Reference to Referactory Anemia
Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risks in patients[1].
Haematological abnormalities are common in systemic lupus erythroematosis. Anemia is found in about 50% of patients.
Read the detailed description
Causes of anemia in SLE:
Anemia due to chronic disease is the most frequent in patients with SLE, representing approximately one-third of the cases [2].
Iron deficiency anemia is also a common cause, usually caused by blood loss (menorrhagia or gastrointestinal bleeding) [3].
Autoimmune hemolytic anemia (AIHA) a classification criteria for SLE [4]. The mechanism is thought to be caused by the destruction of red blood cells through warm or cold antibodies [5]. Patients with AIHA may present with symptoms of anemia or hemolysis or symptoms of an underlying disorder. Severe hemolysis may lead to hepatosplenomegaly, hemoglobinuria, and signs of heart failure [6]. Maanaging patients with AIHA may be challenging because specific therapy should be individualized in accordance with the disease manifestations and its severity [7].
Hemopoietic failure is the suspected to be the result of an immunologically damaged bone marrow (BM) .
Overall, hypocellularity, morphological dysplasia, increased fibrosis, and BM necrosis were common findings in patients with SLE with hemocytopenias, suggesting a primary BM involvement in pathogenesis of the disease, probably mediated by auto-antibodies, immune complexes, and immunopotent T cells [8, 9].
Solid proof of the participation of humoral immune mechanisms in hemopoietic dysfunction was obtained from patients with SLE with aplastic anemia, a BM failure syndrome of a definite immune pathogenesis [10-12].
In these cases, complement dependent or independent autoantibodies were found to suppress erythroid and granulocytic colony formation of BM progenitor cells [10-12].
Targeted by autoantibodies, the progenitor BM cells lead to various syndromes of hemopoietic failure, such as aplastic anaemia, hypoplasia of myeloid line, amegakaryocytic thrombocytopenia, and the extremely rare pure red cell aplasia (PRCA) [13-19].
The presence of the inhibitory autoantibody is typically related to SLE activity and can be suppressed by successful treatment-that is, by immunosuppression. However, PRCA can occur in the absence of disease activity or even precede the appearance of SLE [15].
In our study we will search for the most common causes of anemia in SLE in our environment ,focusing on the most common causes of refractory anemia in SLE.
- Being tested
- Laboratory investigtions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory investigtionsCombination product
Also called Bone marrow study
To study causes of anemia in SLE in our environment and causes of refractory type and its relation to bone marrow affection and different drugs used in SLE
| Study group | Role | What they receive |
|---|---|---|
| Anemia and Systemic lupus erythematosus | Systemic lupus patients with anemia and searching for causes of anemia and what is the most common and what are the causes of refractory anemia and relation of bone marrow affection Receives: Combination Product: Laboratory investigtions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causes of anemia
Assess causes of anemia in SLE and which of them is most common in our locality
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start9 Jul 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Refractory Anemia in Systemic Lupus ErythematosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Saber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210295
- Sponsor's protocol ID
- 121293
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Molina-Rios S, Rojas-Martinez R, Estevez-Ramirez GM, Medina YF. Systemic lupus erythematosus and antiphospholipid syndrome after COVID-19 vaccination. A case report. Mod Rheumatol Case Rep. 2023 Jan 3;7(1):43-46. doi: 10.1093/mrcr/rxac018.
PubMed 35246682Voulgarelis M, Kokori SI, Ioannidis JP, Tzioufas AG, Kyriaki D, Moutsopoulos HM. Anaemia in systemic lupus erythematosus: aetiological profile and the role of erythropoietin. Ann Rheum Dis. 2000 Mar;59(3):217-22. doi: 10.1136/ard.59.3.217.
PubMed 10700431Levine AB, Erkan D. Clinical assessment and management of cytopenias in lupus patients. Curr Rheumatol Rep. 2011 Aug;13(4):291-9. doi: 10.1007/s11926-011-0179-5.
PubMed 21503695Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
PubMed 31385462Jager U, Barcellini W, Broome CM, Gertz MA, Hill A, Hill QA, Jilma B, Kuter DJ, Michel M, Montillo M, Roth A, Zeerleder SS, Berentsen S. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020 May;41:100648. doi: 10.1016/j.blre.2019.100648. Epub 2019 Dec 5.
PubMed 31839434Hill QA, Stamps R, Massey E, Grainger JD, Provan D, Hill A; British Society for Haematology. The diagnosis and management of primary autoimmune haemolytic anaemia. Br J Haematol. 2017 Feb;176(3):395-411. doi: 10.1111/bjh.14478. Epub 2016 Dec 22. No abstract available.
PubMed 28005293Trindade VC, Carneiro-Sampaio M, Bonfa E, Silva CA. An Update on the Management of Childhood-Onset Systemic Lupus Erythematosus. Paediatr Drugs. 2021 Jul;23(4):331-347. doi: 10.1007/s40272-021-00457-z. Epub 2021 Jul 10.
PubMed 34244988Pereira RM, Velloso ER, Menezes Y, Gualandro S, Vassalo J, Yoshinari NH. Bone marrow findings in systemic lupus erythematosus patients with peripheral cytopenias. Clin Rheumatol. 1998;17(3):219-22. doi: 10.1007/BF01451051.
PubMed 9694056Feng CS, Ng MH, Szeto RS, Li EK. Bone marrow findings in lupus patients with pancytopenia. Pathology. 1991 Jan;23(1):5-7. doi: 10.3109/00313029109061430.
PubMed 2062568Bailey FA, Lilly M, Bertoli LF, Ball GV. An antibody that inhibits in vitro bone marrow proliferation in a patient with systemic lupus erythematosus and aplastic anemia. Arthritis Rheum. 1989 Jul;32(7):901-5.
PubMed 2751721Fitchen JJ, Cline MJ, Saxon A, Golde DW. Serum inhibitors of hematopoiesis in a patient with aplastic anemia and systemic lupus erythematosus. Recovery after exchange plasmapheresis. Am J Med. 1979 Mar;66(3):537-42. doi: 10.1016/0002-9343(79)91097-0. No abstract available.
PubMed 433958Brooks BJ Jr, Broxmeyer HE, Bryan CF, Leech SH. Serum inhibitor in systemic lupus erythematosus associated with aplastic anemia. Arch Intern Med. 1984 Jul;144(7):1474-7.
PubMed 6732407Kiely PD, McGuckin CP, Collins DA, Bevan DH, Marsh JC. Erythrocyte aplasia and systemic lupus erythematosus. Lupus. 1995 Oct;4(5):407-11. doi: 10.1177/096120339500400512.
PubMed 8563736Fisch P, Handgretinger R, Schaefer HE. Pure red cell aplasia. Br J Haematol. 2000 Dec;111(4):1010-22. doi: 10.1046/j.1365-2141.2000.02429.x. No abstract available.
PubMed 11167735Habib GS, Saliba WR, Froom P. Pure red cell aplasia and lupus. Semin Arthritis Rheum. 2002 Feb;31(4):279-83. doi: 10.1053/sarh.2002.30440.
PubMed 11836661
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is Behind Anemia in Systemic Lupus Erythematosus With Special Reference to Referactory Anemia
- ClinicalTrials.gov ID
- NCT06210295
- Acronym / sponsor ID
- 121293
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 9 Jul 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risks in patients[1].
Haematological abnormalities are common in systemic lupus erythroematosis. Anemia is found in about 50% of patients.
Detailed description
Causes of anemia in SLE:
Anemia due to chronic disease is the most frequent in patients with SLE, representing approximately one-third of the cases [2].
Iron deficiency anemia is also a common cause, usually caused by blood loss (menorrhagia or gastrointestinal bleeding) [3].
Autoimmune hemolytic anemia (AIHA) a classification criteria for SLE [4]. The mechanism is thought to be caused by the destruction of red blood cells through warm or cold antibodies [5]. Patients with AIHA may present with symptoms of anemia or hemolysis or symptoms of an underlying disorder. Severe hemolysis may lead to hepatosplenomegaly, hemoglobinuria, and signs of heart failure [6]. Maanaging patients with AIHA may be challenging because specific therapy should be individualized in accordance with the disease manifestations and its severity [7].
Hemopoietic failure is the suspected to be the result of an immunologically damaged bone marrow (BM) .
Overall, hypocellularity, morphological dysplasia, increased fibrosis, and BM necrosis were common findings in patients with SLE with hemocytopenias, suggesting a primary BM involvement in pathogenesis of the disease, probably mediated by auto-antibodies, immune complexes, and immunopotent T cells [8, 9].
Solid proof of the participation of humoral immune mechanisms in hemopoietic dysfunction was obtained from patients with SLE with aplastic anemia, a BM failure syndrome of a definite immune pathogenesis [10-12].
In these cases, complement dependent or independent autoantibodies were found to suppress erythroid and granulocytic colony formation of BM progenitor cells [10-12].
Targeted by autoantibodies, the progenitor BM cells lead to various syndromes of hemopoietic failure, such as aplastic anaemia, hypoplasia of myeloid line, amegakaryocytic thrombocytopenia, and the extremely rare pure red cell aplasia (PRCA) [13-19].
The presence of the inhibitory autoantibody is typically related to SLE activity and can be suppressed by successful treatment-that is, by immunosuppression. However, PRCA can occur in the absence of disease activity or even precede the appearance of SLE [15].
In our study we will search for the most common causes of anemia in SLE in our environment ,focusing on the most common causes of refractory anemia in SLE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anemia and Systemic lupus erythematosus | – | Combination Product: Laboratory investigtionsSystemic lupus patients with anemia and searching for causes of anemia and what is the most common and what are the causes of refractory anemia and relation of bone marrow affection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed as systemic lupus erythematosus with anemia aged more than 18 year old
Key inclusion criteria (2 listed)
- -Adult patients (≥18 years) satisfying 2019 EULAR/ACR classification for systemic lupus erythroematosis[24].
- Patients satisfying WHO criteria definition of anemia.
Key exclusion criteria (2 listed)
- Mixed connective tissue disorders.
- Pregnancy .
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 |
|---|---|---|
| Laboratory investigtionsAlso: Bone marrow studyTo study causes of anemia in SLE in our environment and causes of refractory type and its relation to bone marrow affection and different drugs used in SLE | Combination product | Anemia and Systemic lupus erythematosus |
Primary outcome
Causes of anemia
Time frame: One week
Assess causes of anemia in SLE and which of them is most common in our locality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 35246682Molina-Rios S, Rojas-Martinez R, Estevez-Ramirez GM, Medina YF. Systemic lupus erythematosus and antiphospholipid syndrome after COVID-19 vaccination. A case report. Mod Rheumatol Case Rep. 2023 Jan 3;7(1):43-46. doi: 10.1093/mrcr/rxac018.
- Background: PubMed 10700431Voulgarelis M, Kokori SI, Ioannidis JP, Tzioufas AG, Kyriaki D, Moutsopoulos HM. Anaemia in systemic lupus erythematosus: aetiological profile and the role of erythropoietin. Ann Rheum Dis. 2000 Mar;59(3):217-22. doi: 10.1136/ard.59.3.217.
- Background: PubMed 21503695Levine AB, Erkan D. Clinical assessment and management of cytopenias in lupus patients. Curr Rheumatol Rep. 2011 Aug;13(4):291-9. doi: 10.1007/s11926-011-0179-5.
- Background: PubMed 31385462Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
- Background: PubMed 31839434Jager U, Barcellini W, Broome CM, Gertz MA, Hill A, Hill QA, Jilma B, Kuter DJ, Michel M, Montillo M, Roth A, Zeerleder SS, Berentsen S. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020 May;41:100648. doi: 10.1016/j.blre.2019.100648. Epub 2019 Dec 5.
- Background: PubMed 28005293Hill QA, Stamps R, Massey E, Grainger JD, Provan D, Hill A; British Society for Haematology. The diagnosis and management of primary autoimmune haemolytic anaemia. Br J Haematol. 2017 Feb;176(3):395-411. doi: 10.1111/bjh.14478. Epub 2016 Dec 22. No abstract available.
- Background: PubMed 34244988Trindade VC, Carneiro-Sampaio M, Bonfa E, Silva CA. An Update on the Management of Childhood-Onset Systemic Lupus Erythematosus. Paediatr Drugs. 2021 Jul;23(4):331-347. doi: 10.1007/s40272-021-00457-z. Epub 2021 Jul 10.
- Background: PubMed 9694056Pereira RM, Velloso ER, Menezes Y, Gualandro S, Vassalo J, Yoshinari NH. Bone marrow findings in systemic lupus erythematosus patients with peripheral cytopenias. Clin Rheumatol. 1998;17(3):219-22. doi: 10.1007/BF01451051.
- Background: PubMed 2062568Feng CS, Ng MH, Szeto RS, Li EK. Bone marrow findings in lupus patients with pancytopenia. Pathology. 1991 Jan;23(1):5-7. doi: 10.3109/00313029109061430.
- Background: PubMed 2751721Bailey FA, Lilly M, Bertoli LF, Ball GV. An antibody that inhibits in vitro bone marrow proliferation in a patient with systemic lupus erythematosus and aplastic anemia. Arthritis Rheum. 1989 Jul;32(7):901-5.
- Background: PubMed 433958Fitchen JJ, Cline MJ, Saxon A, Golde DW. Serum inhibitors of hematopoiesis in a patient with aplastic anemia and systemic lupus erythematosus. Recovery after exchange plasmapheresis. Am J Med. 1979 Mar;66(3):537-42. doi: 10.1016/0002-9343(79)91097-0. No abstract available.
- Background: PubMed 6732407Brooks BJ Jr, Broxmeyer HE, Bryan CF, Leech SH. Serum inhibitor in systemic lupus erythematosus associated with aplastic anemia. Arch Intern Med. 1984 Jul;144(7):1474-7.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Anemia in Systemic Lupus Erythematosis, run by Assiut University.
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 2 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Causes of anemia (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210295, which also lists 22 linked publications.
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 6 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.