Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-03-03 @ 5:43 AM
Study NCT ID:
NCT03617250
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2018-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2018-07-22', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of inflammation in rheumatoid arthritis', 'timeFrame': 'Average one year', 'description': 'By using Disease Activity Score-28 to classify patients into patients with active disease and patients with remission'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '16142705', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21968329', 'type': 'BACKGROUND', 'citation': 'Azab 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.'}, {'pmid': '19452619', 'type': 'BACKGROUND', 'citation': 'Briggs 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.'}, {'pmid': '15759949', 'type': 'BACKGROUND', 'citation': 'Colglazier 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.'}, {'pmid': '23221583', 'type': 'BACKGROUND', 'citation': 'Hobbs 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.'}, {'pmid': '18403245', 'type': 'BACKGROUND', 'citation': 'Kisacik 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.'}, {'pmid': '22573523', 'type': 'BACKGROUND', 'citation': 'Kocyigit 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.'}, {'pmid': '22150039', 'type': 'BACKGROUND', 'citation': 'McInnes 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.'}, {'pmid': '24911455', 'type': 'BACKGROUND', 'citation': 'Ugur 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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nTherefore 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.\n\nSystemic 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 .\n\nParameters 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 .\n\nPlatelet count, mean platelet volume (MPV), platelet distribution width (PDW) are three useful indices of platelet function reflecting the platelet production rate. .\n\nGokmen 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.\n\nPrevious 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 .\n\nBased 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.\n\nUslu 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* One hundred patients suffering from Rheumatoid arthritis .\n\nExclusion Criteria:\n\nPatients with:\n\n* Diabetes mellitus, hypertension, acute or chronic renal failure, acute or Chronic liver disease obstructive lung disease, Coronary artery disease.\n* Hematologic disorders other than anemia or history of receiving blood transfusion during the past three months.\n* Acute or chronic infections.\n* Pregnancy or in the postpartum period.\n* History of allergic diseases or any malignant disease.\n* Patients with leucocytic count less than 4000 u/l'}, 'identificationModule': {'nctId': 'NCT03617250', 'briefTitle': 'Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Correlation Between Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio With Disease Activity in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'RHEUMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active patients', 'description': '50 rheumatoid patients with active disease according to Disease Activity Score-28', 'interventionNames': ['Other: Disease Activity Score-28']}, {'label': 'patients with remission', 'description': '50 patients with remission according to Disease Activity Score-28', 'interventionNames': ['Other: Disease Activity Score-28']}], 'interventions': [{'name': 'Disease Activity Score-28', 'type': 'OTHER', 'description': 'Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28', 'armGroupLabels': ['Active patients', 'patients with remission']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Noha Foad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Noha Foad', 'investigatorAffiliation': 'Assiut University'}}}}