Rheumatic DiseasesNCT04110184
Haematological Indices in Systemic Lupus Erythematosus
An observational study of Rheumatic Diseases and Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
The aim of this study is to investigate the value of several hematological indices such as: neutrophil-lymphocyte ratio. platelet-lymphocyte ratio. red blood cell distribution width. mean platelet volume (MPV), RDW/platelet ratio. neutrophil / C3 ratio. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases, Systemic Lupus Erythematosus
- What is being tested?
- Systemic lupus erythematosus disease activity index (SLEDAI)
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Feb 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 42 systemic lupus patients divided into two groups. The first group with active disease and the second group with inactive. There are 42 healthy participants age and sex matched as control group.
Who may be able to join
- 1. SLE patients who fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (Petri et al., 2012).
- 2. All patients > 18 years old.
Who cannot join
- 1. Patients with other autoimmune disease such as: Rheumatoid arthritis (RA), Mixed connective tissue disease (MTCD), Dermatomyositis (DM) and Systemic Sclerosis (SS).
- 2. Patients with malignant diseases.
- 3. Patients with coronary artery disease, cerebrovascular disease, renal and liver diseases.
- 4. Patients with evidence of any concomitant inflammatory disease. Acute infection or chronic inflammatory status.
- 5. Patients with hematological disease or history of blood transfusion in the previous 4 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity
The aim of this study is to investigate the value of several hematological indices such as:
- neutrophil-lymphocyte ratio.
- platelet-lymphocyte ratio.
- red blood cell distribution width.
- mean platelet volume (MPV), RDW/platelet ratio.
- neutrophil / C3 ratio.
- All these as biomarkers of activity in systemic lupus erythematosis patients.
Read the detailed description
Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations of the patients.
The pathogenesis of SLE remains unclear, but environmental triggers and genetic factors contribute to the destruction of immune tolerance systems, the production of immunological lymphocytes, antibodies, and inflammatory cytokines.
The clinical manifestations of SLE range from constitutional symptoms, such as fever, sweats, weight loss, joint pain and skin rashes (including the classic butter fly rash), to more serious features, including the involvement of the central nervous system and kidneys.
However, to make a clinical diagnosis of SLE, The SLICC criteria require either that a patient satisfy at least 4 of 17 criteria, including at least 1 of the 11 clinical criteria and one of the six immunologic criteria, or that the patient has biopsy-proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA) or anti-double-stranded DNA (dsDNA) antibodies. Patients with higher disease activity often present severer damage of tissues and organs.
SLE is characterized by high heterogeneity, a complex pathophysiology and various clinical manifestations; thus, no test alone is sufficiently sensitive or specific for diagnosis. Active and inactive SLE patients were evaluated according to SLE disease activity index (SLEDAI).There is significant interest in the identification of biomarkers that can predict SLE and quantify disease activity.
Neutrophils and lymphocytes play major roles in inflammatory processes. Under inflammatory conditions, neutrophil and lymphocyte counts undergo temporary changes. Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.
As an index of systemic inflammation, NLR has been identified to be a useful index for the differential diagnosis or prognostic prediction of diseases. NLR can be calculated easily and less costly as compared with detection of other inflammatory cytokines that could be used as biomarkers for inflammatory response or disease activity in SLE patient.
The platelet-to-lymphocyte ratio (PLR), red blood cell distribution width (RDW), and similar parameters [ eg, neutrophil-to-lymphocyte ratio (NLR) and mean platelet volume (MPV) ], which can be easily obtained using peripheral blood parameters, have been regarded as novel, accurate inflammatory biomarkers in many diseases.
MPV is a biomarker of platelet turnover, whereas platelet activation is a marker of inflammation. Previous studies have reported that MPV is correlated with the inflammatory process and disease activity in RA and ankylosing spondylitis, but the relationship between MPV and SLE remains controversial.
Complement system activation, production and partial deposition of complement fragments, and subsequent inflammation all play critical roles in the pathogenesis of SLE. During the complement activation pathway, Complement 3 was at the core position.
- Conditions
- Rheumatic Diseases, Systemic Lupus Erythematosus
- Being tested
- Systemic lupus erythematosus disease activity index (SLEDAI)
- Medical subject headings
- Rheumatic Diseases, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic lupus erythematosus disease activity index (SLEDAI)Other
The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease
| Study group | Role | What they receive |
|---|---|---|
| active systemic lupus erythematosus | Not described Receives: Other: Systemic lupus erythematosus disease activity index (SLEDAI) | |
| inactive systemic lupus erythematosus | Not described Receives: Other: Systemic lupus erythematosus disease activity index (SLEDAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematological indices and their association with activity in systemic lupus erythematosis patients.
investigate the value of several hematological indices and their association with activity in systemic lupus erythematosis patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AA Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110184
- Sponsor's protocol ID
- Haematological indices
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gordon C, Amissah-Arthur MB, Gayed M, Brown S, Bruce IN, D'Cruz D, Empson B, Griffiths B, Jayne D, Khamashta M, Lightstone L, Norton P, Norton Y, Schreiber K, Isenberg D; British Society for Rheumatology Standards, Audit and Guidelines Working Group. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults: Executive Summary. Rheumatology (Oxford). 2018 Jan 1;57(1):14-18. doi: 10.1093/rheumatology/kex291. No abstract available.
PubMed 29029296Gorial FI (2018) A Clinical Utility of Neutrophil Lymphocyte Ratio as A Prognostic Indicator of Systemic Lupus Erythematosus Disease Activity. J. Pharm. Sci. & Res. 10(3) : 637-639.
La Paglia GMC, Leone MC, Lepri G, Vagelli R, Valentini E, Alunno A, Tani C. One year in review 2017: systemic lupus erythematosus. Clin Exp Rheumatol. 2017 Jul-Aug;35(4):551-561. Epub 2017 Jul 11.
PubMed 28721860Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
PubMed 1599520Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
PubMed 22553077Yu H, Jiang L, Yao L, Gan C, Han X, Liu R, Su N. Predictive value of the neutrophil-to-lymphocyte ratio and hemoglobin insystemic lupus erythematosus. Exp Ther Med. 2018 Aug;16(2):1547-1553. doi: 10.3892/etm.2018.6309. Epub 2018 Jun 13.
PubMed 30112073Yu J, Zeng T, Wu Y, Tian Y, Tan L, Duan X, Wu Q, Li H, Yu L. Neutrophil-to-C3 ratio and neutrophil-to-lymphocyte ratio were associated with disease activity in patients with systemic lupus erythematosus. J Clin Lab Anal. 2019 Jan;33(1):e22633. doi: 10.1002/jcla.22633. Epub 2018 Aug 20.
PubMed 30129188Xie S, Chen X. Red blood cell distribution width-to-platelet ratio as a disease activity-associated factor in systemic lupus erythematosus. Medicine (Baltimore). 2018 Sep;97(39):e12342. doi: 10.1097/MD.0000000000012342.
PubMed 30278511Qin B, Ma N, Tang Q, Wei T, Yang M, Fu H, Hu Z, Liang Y, Yang Z, Zhong R. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) were useful markers in assessment of inflammatory response and disease activity in SLE patients. Mod Rheumatol. 2016;26(3):372-6. doi: 10.3109/14397595.2015.1091136. Epub 2016 Mar 4.
PubMed 26403379Balta S, Aparci M, Ozturk C, Demirkol S, Celik T. Neutrophil-lymphocyte ratio as an useful mortality marker. Am J Emerg Med. 2014 Dec;32(12):1546-7. doi: 10.1016/j.ajem.2014.09.040. Epub 2014 Oct 2. No abstract available.
PubMed 25315881Safak S, Uslu AU, Serdal K, Turker T, Soner S, Lutfi A. Association between mean platelet volume levels and inflammation in SLE patients presented with arthritis. Afr Health Sci. 2014 Dec;14(4):919-24. doi: 10.4314/ahs.v14i4.21.
PubMed 25834502Ayna AB, Ermurat S, Coskun BN, Harman H, Pehlivan Y. Neutrophil to Lymphocyte Ratio and Mean Platelet Volume as Inflammatory Indicators in Systemic Lupus Erythematosus Nephritis. Arch Rheumatol. 2016 Aug 17;32(1):21-25. doi: 10.5606/ArchRheumatol.2017.5886. eCollection 2017 Mar.
PubMed 30375538
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity
- ClinicalTrials.gov ID
- NCT04110184
- Acronym / sponsor ID
- Haematological indices
- Conditions
- Rheumatic Diseases, Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 1 Oct 2019 (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.
The aim of this study is to investigate the value of several hematological indices such as:
- neutrophil-lymphocyte ratio.
- platelet-lymphocyte ratio.
- red blood cell distribution width.
- mean platelet volume (MPV), RDW/platelet ratio.
- neutrophil / C3 ratio.
- All these as biomarkers of activity in systemic lupus erythematosis patients.
Detailed description
Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations of the patients.
The pathogenesis of SLE remains unclear, but environmental triggers and genetic factors contribute to the destruction of immune tolerance systems, the production of immunological lymphocytes, antibodies, and inflammatory cytokines.
The clinical manifestations of SLE range from constitutional symptoms, such as fever, sweats, weight loss, joint pain and skin rashes (including the classic butter fly rash), to more serious features, including the involvement of the central nervous system and kidneys.
However, to make a clinical diagnosis of SLE, The SLICC criteria require either that a patient satisfy at least 4 of 17 criteria, including at least 1 of the 11 clinical criteria and one of the six immunologic criteria, or that the patient has biopsy-proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA) or anti-double-stranded DNA (dsDNA) antibodies. Patients with higher disease activity often present severer damage of tissues and organs.
SLE is characterized by high heterogeneity, a complex pathophysiology and various clinical manifestations; thus, no test alone is sufficiently sensitive or specific for diagnosis. Active and inactive SLE patients were evaluated according to SLE disease activity index (SLEDAI).There is significant interest in the identification of biomarkers that can predict SLE and quantify disease activity.
Neutrophils and lymphocytes play major roles in inflammatory processes. Under inflammatory conditions, neutrophil and lymphocyte counts undergo temporary changes. Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.
As an index of systemic inflammation, NLR has been identified to be a useful index for the differential diagnosis or prognostic prediction of diseases. NLR can be calculated easily and less costly as compared with detection of other inflammatory cytokines that could be used as biomarkers for inflammatory response or disease activity in SLE patient.
The platelet-to-lymphocyte ratio (PLR), red blood cell distribution width (RDW), and similar parameters [ eg, neutrophil-to-lymphocyte ratio (NLR) and mean platelet volume (MPV) ], which can be easily obtained using peripheral blood parameters, have been regarded as novel, accurate inflammatory biomarkers in many diseases.
MPV is a biomarker of platelet turnover, whereas platelet activation is a marker of inflammation. Previous studies have reported that MPV is correlated with the inflammatory process and disease activity in RA and ankylosing spondylitis, but the relationship between MPV and SLE remains controversial.
Complement system activation, production and partial deposition of complement fragments, and subsequent inflammation all play critical roles in the pathogenesis of SLE. During the complement activation pathway, Complement 3 was at the core position.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active systemic lupus erythematosus | – | Other: Systemic lupus erythematosus disease activity index (SLEDAI) |
| inactive systemic lupus erythematosus | – | Other: Systemic lupus erythematosus disease activity index (SLEDAI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 42 systemic lupus patients divided into two groups. The first group with active disease and the second group with inactive. There are 42 healthy participants age and sex matched as control group.
Key inclusion criteria (2 listed)
- 1. SLE patients who fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (Petri et al., 2012).
- 2. All patients > 18 years old.
Key exclusion criteria (5 listed)
- 1. Patients with other autoimmune disease such as: Rheumatoid arthritis (RA), Mixed connective tissue disease (MTCD), Dermatomyositis (DM) and Systemic Sclerosis (SS).
- 2. Patients with malignant diseases.
- 3. Patients with coronary artery disease, cerebrovascular disease, renal and liver diseases.
- 4. Patients with evidence of any concomitant inflammatory disease. Acute infection or chronic inflammatory status.
- 5. Patients with hematological disease or history of blood transfusion in the previous 4 months.
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 |
|---|---|---|
| Systemic lupus erythematosus disease activity index (SLEDAI)The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease | Other | active systemic lupus erythematosus, inactive systemic lupus erythematosus |
Primary outcome
hematological indices and their association with activity in systemic lupus erythematosis patients.
Time frame: baseline
investigate the value of several hematological indices and their association with activity in systemic lupus erythematosis patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 29029296Gordon C, Amissah-Arthur MB, Gayed M, Brown S, Bruce IN, D'Cruz D, Empson B, Griffiths B, Jayne D, Khamashta M, Lightstone L, Norton P, Norton Y, Schreiber K, Isenberg D; British Society for Rheumatology Standards, Audit and Guidelines Working Group. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults: Executive Summary. Rheumatology (Oxford). 2018 Jan 1;57(1):14-18. doi: 10.1093/rheumatology/kex291. No abstract available.
- BackgroundGorial FI (2018) A Clinical Utility of Neutrophil Lymphocyte Ratio as A Prognostic Indicator of Systemic Lupus Erythematosus Disease Activity. J. Pharm. Sci. & Res. 10(3) : 637-639.
- Background: PubMed 28721860La Paglia GMC, Leone MC, Lepri G, Vagelli R, Valentini E, Alunno A, Tani C. One year in review 2017: systemic lupus erythematosus. Clin Exp Rheumatol. 2017 Jul-Aug;35(4):551-561. Epub 2017 Jul 11.
- Background: PubMed 1599520Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
- Background: PubMed 22553077Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
- Background: PubMed 30112073Yu H, Jiang L, Yao L, Gan C, Han X, Liu R, Su N. Predictive value of the neutrophil-to-lymphocyte ratio and hemoglobin insystemic lupus erythematosus. Exp Ther Med. 2018 Aug;16(2):1547-1553. doi: 10.3892/etm.2018.6309. Epub 2018 Jun 13.
- Background: PubMed 30129188Yu J, Zeng T, Wu Y, Tian Y, Tan L, Duan X, Wu Q, Li H, Yu L. Neutrophil-to-C3 ratio and neutrophil-to-lymphocyte ratio were associated with disease activity in patients with systemic lupus erythematosus. J Clin Lab Anal. 2019 Jan;33(1):e22633. doi: 10.1002/jcla.22633. Epub 2018 Aug 20.
- Background: PubMed 30278511Xie S, Chen X. Red blood cell distribution width-to-platelet ratio as a disease activity-associated factor in systemic lupus erythematosus. Medicine (Baltimore). 2018 Sep;97(39):e12342. doi: 10.1097/MD.0000000000012342.
- Background: PubMed 26403379Qin B, Ma N, Tang Q, Wei T, Yang M, Fu H, Hu Z, Liang Y, Yang Z, Zhong R. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) were useful markers in assessment of inflammatory response and disease activity in SLE patients. Mod Rheumatol. 2016;26(3):372-6. doi: 10.3109/14397595.2015.1091136. Epub 2016 Mar 4.
- Background: PubMed 25315881Balta S, Aparci M, Ozturk C, Demirkol S, Celik T. Neutrophil-lymphocyte ratio as an useful mortality marker. Am J Emerg Med. 2014 Dec;32(12):1546-7. doi: 10.1016/j.ajem.2014.09.040. Epub 2014 Oct 2. No abstract available.
- Background: PubMed 25834502Safak S, Uslu AU, Serdal K, Turker T, Soner S, Lutfi A. Association between mean platelet volume levels and inflammation in SLE patients presented with arthritis. Afr Health Sci. 2014 Dec;14(4):919-24. doi: 10.4314/ahs.v14i4.21.
- Results publication: PubMed 30375538Ayna AB, Ermurat S, Coskun BN, Harman H, Pehlivan Y. Neutrophil to Lymphocyte Ratio and Mean Platelet Volume as Inflammatory Indicators in Systemic Lupus Erythematosus Nephritis. Arch Rheumatol. 2016 Aug 17;32(1):21-25. doi: 10.5606/ArchRheumatol.2017.5886. eCollection 2017 Mar.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Systemic Lupus Erythematosus, 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 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 1 Oct 2019. 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?
Contact Alaa Atef, Resident doctor (01114341538, alaa.atef_2012@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematological indices and their association with activity in systemic lupus erythematosis patients. (time frame: baseline). 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 NCT04110184, which also lists 12 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 1 Oct 2019.