Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03617250
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Noha Foad, Assiut University

Tracking Information
First Submitted Date July 22, 2018
First Posted Date August 6, 2018
Last Update Posted Date July 12, 2019
Estimated Study Start Date November 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03617250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis
Official Title The Correlation Between Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio With Disease Activity in Rheumatoid Arthritis
Brief 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 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Rheumatoid Arthritis
Intervention Other: Disease Activity Score-28
Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28
Study Groups/Cohorts
  • Active patients
    50 rheumatoid patients with active disease according to Disease Activity Score-28
    Intervention: Other: Disease Activity Score-28
  • patients with remission
    50 patients with remission according to Disease Activity Score-28
    Intervention: Other: Disease Activity Score-28
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 3, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • One hundred patients suffering from Rheumatoid arthritis .

Exclusion Criteria:

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03617250
Other Study ID Numbers RHEUMA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Noha Foad, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2018