Rheumatoid ArthritisNCT03617250
Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Assiut University at 1 site in Egypt.
Trial summary
Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing- remitting course.Disease activity assessment is important for rheumatoid arthritis management .Neutrophil lymphocyte ratio and platelet lymphocyte ratio are associated with inflammatory… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Disease Activity Score-28
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Aug 2022
- 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: One hundred rheumatoid arthritis patients divided into two groups. The first group with active disease and the second group with disease remission. There are 50 healthy participants age and sex matched as control group.
Who may be able to join
- One hundred patients suffering from Rheumatoid arthritis .
Who cannot join
- Patients with:
- Diabetes mellitus, hypertension, acute or chronic renal failure, acute or Chronic liver disease obstructive lung disease, Coronary artery disease.
- Hematologic disorders other than anemia or history of receiving blood transfusion during the past three months.
- Acute or chronic infections.
- Pregnancy or in the postpartum period.
- History of allergic diseases or any malignant disease.
- Patients with leucocytic count less than 4000 u/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation Between Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio With Disease Activity in Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing- remitting course.Disease activity assessment is important for rheumatoid arthritis management .Neutrophil lymphocyte ratio and platelet lymphocyte ratio are associated with inflammatory status and can be used to assess disease activity in rheumatoid arthritis
Read the detailed description
Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing - remitting course and induce severe disability . Rheumatoid arthritis is an inflammatory disease that causes devastating joint destruction if patients are not appropriately treated. It is characterized by symmetric joint involvement, erosion and deformity in the joints as a result of synovial inflammation .Inflammation is the key determinant and primary underlying mechanism leading to disability and increased mortality in patients with rheumatoid arthritis.Disease activity assessment is important for rheumatoid arthritis management, since it could greatly affect the clinical decision. Current disease activity assessment mainly depend on clinical symptoms, signs and laboratory tests. laboratory Investigations are much preferred due to the advantage of less observer variations.
Therefore assessment of inflammation in rheumatoid arthritis with reliable markers is crucial to predict long term outcome of a particular patient. The most commonly used markers for this purpose are ESR and CRP in daily practice. However both of these markers have some limitations such as reflection of short-term inflammatory activity and low discrimination ability with other superimposed conditions.
Systemic inflammation is associated with changes in circulating blood cells quantity and composition. Normochromic anemia, thrombocytosis, neutrophilia and lymphopenia usually occur with many inflammatory conditions so the features of circulating blood cell components can be used for the assessment of inflammatory activity .
Parameters of hemogram, particularly those including immune system elements are important in the assessment of different diseases and or sign. Immune system elements involve the neutrophils, lymphocytes and platelets that have a role in the control of inflammation, while also undergoing changes secondary to inflammation. Patients with rheumatoid arthritis may be found with increasing platelet counts during active stages of the disease. The counts decrease up on remission of inflammation but detailed role played by platelets remains unobvious .
Platelet count, mean platelet volume (MPV), platelet distribution width (PDW) are three useful indices of platelet function reflecting the platelet production rate. .
Gokmen et al 2016 concluded that MPV and neutrophil lymphocyte ratio (NLR) together with acute phase reactant C.reactive Protein(CRP), erythrocyte sedimentation rate (ESR) can be a useful indices for showing inflammation in RA patients and demonstrated that MPV negatively correlated with CRP and NLR positively correlated with ESR, CRP and anti cyclic citrullinated peptide antibody (antiCCP). The author concluded that high NLR levels in patients with RA is important in predicting prognosis of disease and development of more joint damage and hypothesized that NLR may be Considered to be an indicator of inflammation, disease activity and disease prognosis.
Previous studies have shown that increased neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are associated with poor prognosis of various inflammatory related diseases such as cancer, chronic kidney disease , acute pancreatitis ) and myocardial infarction . This may be due to the fact that both PLR and NLR are associated with the inflammatory status .
Based on these Studies recently Fu el at., in 2015 hypothesized that both NLR and PLR correlated with the disease activity of RA and suggested that NLR and PLR may be indices for assessment of RA disease activity.
Uslu et al 2015 demonstrated that NLR and PLR were elevated in rheumatoid arthritis patients with active disease compared with patients in remission. So they concluded that NLR and PLR were two new inflammatory markers which could be used to assess disease activity in patients with rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- Disease Activity Score-28
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease Activity Score-28Other
Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28
| Study group | Role | What they receive |
|---|---|---|
| Active patients | 50 rheumatoid patients with active disease according to Disease Activity Score-28 Receives: Other: Disease Activity Score-28 | |
| patients with remission | 50 patients with remission according to Disease Activity Score-28 Receives: Other: Disease Activity Score-28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of inflammation in rheumatoid arthritis
By using Disease Activity Score-28 to classify patients into patients with active disease and patients with remission
Measured: Average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Aug 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Foad, Assiut University
- Investigators
- Noha Foad, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617250
- Sponsor's protocol ID
- RHEUMA
- Status last verified
- May 2020
- First submitted
- 22 Jul 2018
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aletaha D, Ward MM, Machold KP, Nell VP, Stamm T, Smolen JS. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Arthritis Rheum. 2005 Sep;52(9):2625-36. doi: 10.1002/art.21235.
PubMed 16142705Azab B, Jaglall N, Atallah JP, Lamet A, Raja-Surya V, Farah B, Lesser M, Widmann WD. Neutrophil-lymphocyte ratio as a predictor of adverse outcomes of acute pancreatitis. Pancreatology. 2011;11(4):445-52. doi: 10.1159/000331494. Epub 2011 Sep 28.
PubMed 21968329Briggs C. Quality counts: new parameters in blood cell counting. Int J Lab Hematol. 2009 Jun;31(3):277-97. doi: 10.1111/j.1751-553x.2009.01160.x.
PubMed 19452619Colglazier CL, Sutej PG. Laboratory testing in the rheumatic diseases: a practical review. South Med J. 2005 Feb;98(2):185-91. doi: 10.1097/01.SMJ.0000153572.22346.E9.
PubMed 15759949Hobbs KF, Cohen MD. Rheumatoid arthritis disease measurement: a new old idea. Rheumatology (Oxford). 2012 Dec;51 Suppl 6:vi21-7. doi: 10.1093/rheumatology/kes282.
PubMed 23221583Kisacik B, Tufan A, Kalyoncu U, Karadag O, Akdogan A, Ozturk MA, Kiraz S, Ertenli I, Calguneri M. Mean platelet volume (MPV) as an inflammatory marker in ankylosing spondylitis and rheumatoid arthritis. Joint Bone Spine. 2008 May;75(3):291-4. doi: 10.1016/j.jbspin.2007.06.016. Epub 2008 Apr 9.
PubMed 18403245Kocyigit I, Eroglu E, Unal A, Sipahioglu MH, Tokgoz B, Oymak O, Utas C. Role of neutrophil/lymphocyte ratio in prediction of disease progression in patients with stage-4 chronic kidney disease. J Nephrol. 2013 Mar-Apr;26(2):358-65. doi: 10.5301/jn.5000152. Epub 2012 May 8.
PubMed 22573523McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
PubMed 22150039Ugur M, Gul M, Bozbay M, Cicek G, Uyarel H, Koroglu B, Uluganyan M, Aslan S, Tusun E, Surgit O, Akkaya E, Eren M. The relationship between platelet to lymphocyte ratio and the clinical outcomes in ST elevation myocardial infarction underwent primary coronary intervention. Blood Coagul Fibrinolysis. 2014 Dec;25(8):806-11. doi: 10.1097/MBC.0000000000000150.
PubMed 24911455
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio With Disease Activity in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03617250
- Acronym / sponsor ID
- RHEUMA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Aug 2018 (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.
Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing- remitting course.Disease activity assessment is important for rheumatoid arthritis management .Neutrophil lymphocyte ratio and platelet lymphocyte ratio are associated with inflammatory status and can be used to assess disease activity in rheumatoid arthritis
Detailed description
Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing - remitting course and induce severe disability . Rheumatoid arthritis is an inflammatory disease that causes devastating joint destruction if patients are not appropriately treated. It is characterized by symmetric joint involvement, erosion and deformity in the joints as a result of synovial inflammation .Inflammation is the key determinant and primary underlying mechanism leading to disability and increased mortality in patients with rheumatoid arthritis.Disease activity assessment is important for rheumatoid arthritis management, since it could greatly affect the clinical decision. Current disease activity assessment mainly depend on clinical symptoms, signs and laboratory tests. laboratory Investigations are much preferred due to the advantage of less observer variations.
Therefore assessment of inflammation in rheumatoid arthritis with reliable markers is crucial to predict long term outcome of a particular patient. The most commonly used markers for this purpose are ESR and CRP in daily practice. However both of these markers have some limitations such as reflection of short-term inflammatory activity and low discrimination ability with other superimposed conditions.
Systemic inflammation is associated with changes in circulating blood cells quantity and composition. Normochromic anemia, thrombocytosis, neutrophilia and lymphopenia usually occur with many inflammatory conditions so the features of circulating blood cell components can be used for the assessment of inflammatory activity .
Parameters of hemogram, particularly those including immune system elements are important in the assessment of different diseases and or sign. Immune system elements involve the neutrophils, lymphocytes and platelets that have a role in the control of inflammation, while also undergoing changes secondary to inflammation. Patients with rheumatoid arthritis may be found with increasing platelet counts during active stages of the disease. The counts decrease up on remission of inflammation but detailed role played by platelets remains unobvious .
Platelet count, mean platelet volume (MPV), platelet distribution width (PDW) are three useful indices of platelet function reflecting the platelet production rate. .
Gokmen et al 2016 concluded that MPV and neutrophil lymphocyte ratio (NLR) together with acute phase reactant C.reactive Protein(CRP), erythrocyte sedimentation rate (ESR) can be a useful indices for showing inflammation in RA patients and demonstrated that MPV negatively correlated with CRP and NLR positively correlated with ESR, CRP and anti cyclic citrullinated peptide antibody (antiCCP). The author concluded that high NLR levels in patients with RA is important in predicting prognosis of disease and development of more joint damage and hypothesized that NLR may be Considered to be an indicator of inflammation, disease activity and disease prognosis.
Previous studies have shown that increased neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are associated with poor prognosis of various inflammatory related diseases such as cancer, chronic kidney disease , acute pancreatitis ) and myocardial infarction . This may be due to the fact that both PLR and NLR are associated with the inflammatory status .
Based on these Studies recently Fu el at., in 2015 hypothesized that both NLR and PLR correlated with the disease activity of RA and suggested that NLR and PLR may be indices for assessment of RA disease activity.
Uslu et al 2015 demonstrated that NLR and PLR were elevated in rheumatoid arthritis patients with active disease compared with patients in remission. So they concluded that NLR and PLR were two new inflammatory markers which could be used to assess disease activity in patients with rheumatoid arthritis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active patients | – | Other: Disease Activity Score-2850 rheumatoid patients with active disease according to Disease Activity Score-28 |
| patients with remission | – | Other: Disease Activity Score-2850 patients with remission according to Disease Activity Score-28 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred rheumatoid arthritis patients divided into two groups. The first group with active disease and the second group with disease remission. There are 50 healthy participants age and sex matched as control group.
Key inclusion criteria (1 listed)
- One hundred patients suffering from Rheumatoid arthritis .
Key exclusion criteria (7 listed)
- Diabetes mellitus, hypertension, acute or chronic renal failure, acute or Chronic liver disease obstructive lung disease, Coronary artery disease.
- Hematologic disorders other than anemia or history of receiving blood transfusion during the past three months.
- Acute or chronic infections.
- Pregnancy or in the postpartum period.
- History of allergic diseases or any malignant disease.
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 |
|---|---|---|
| Disease Activity Score-28Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28 | Other | Active patients, patients with remission |
Primary outcome
Assessment of inflammation in rheumatoid arthritis
Time frame: Average one year
By using Disease Activity Score-28 to classify patients into patients with active disease and patients with remission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 16142705Aletaha D, Ward MM, Machold KP, Nell VP, Stamm T, Smolen JS. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Arthritis Rheum. 2005 Sep;52(9):2625-36. doi: 10.1002/art.21235.
- Background: PubMed 21968329Azab B, Jaglall N, Atallah JP, Lamet A, Raja-Surya V, Farah B, Lesser M, Widmann WD. Neutrophil-lymphocyte ratio as a predictor of adverse outcomes of acute pancreatitis. Pancreatology. 2011;11(4):445-52. doi: 10.1159/000331494. Epub 2011 Sep 28.
- Background: PubMed 19452619Briggs C. Quality counts: new parameters in blood cell counting. Int J Lab Hematol. 2009 Jun;31(3):277-97. doi: 10.1111/j.1751-553x.2009.01160.x.
- Background: PubMed 15759949Colglazier CL, Sutej PG. Laboratory testing in the rheumatic diseases: a practical review. South Med J. 2005 Feb;98(2):185-91. doi: 10.1097/01.SMJ.0000153572.22346.E9.
- Background: PubMed 23221583Hobbs KF, Cohen MD. Rheumatoid arthritis disease measurement: a new old idea. Rheumatology (Oxford). 2012 Dec;51 Suppl 6:vi21-7. doi: 10.1093/rheumatology/kes282.
- Background: PubMed 18403245Kisacik B, Tufan A, Kalyoncu U, Karadag O, Akdogan A, Ozturk MA, Kiraz S, Ertenli I, Calguneri M. Mean platelet volume (MPV) as an inflammatory marker in ankylosing spondylitis and rheumatoid arthritis. Joint Bone Spine. 2008 May;75(3):291-4. doi: 10.1016/j.jbspin.2007.06.016. Epub 2008 Apr 9.
- Background: PubMed 22573523Kocyigit I, Eroglu E, Unal A, Sipahioglu MH, Tokgoz B, Oymak O, Utas C. Role of neutrophil/lymphocyte ratio in prediction of disease progression in patients with stage-4 chronic kidney disease. J Nephrol. 2013 Mar-Apr;26(2):358-65. doi: 10.5301/jn.5000152. Epub 2012 May 8.
- Background: PubMed 22150039McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
- Background: PubMed 24911455Ugur M, Gul M, Bozbay M, Cicek G, Uyarel H, Koroglu B, Uluganyan M, Aslan S, Tusun E, Surgit O, Akkaya E, Eren M. The relationship between platelet to lymphocyte ratio and the clinical outcomes in ST elevation myocardial infarction underwent primary coronary intervention. Blood Coagul Fibrinolysis. 2014 Dec;25(8):806-11. doi: 10.1097/MBC.0000000000000150.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Noha Foad, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of inflammation in rheumatoid arthritis (time frame: Average one year). 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 NCT03617250, which also lists 9 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 Feb 2024.