NCT03617250

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
3 years until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 6, 2024

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

July 22, 2018

Last Update Submit

February 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of inflammation in rheumatoid arthritis

    By using Disease Activity Score-28 to classify patients into patients with active disease and patients with remission

    Average one year

Study Arms (2)

Active patients

50 rheumatoid patients with active disease according to Disease Activity Score-28

Other: Disease Activity Score-28

patients with remission

50 patients with remission according to Disease Activity Score-28

Other: Disease Activity Score-28

Interventions

Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28

Active patientspatients with remission

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • One hundred patients suffering from Rheumatoid arthritis .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (9)

  • 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: 16142705BACKGROUND
  • 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: 21968329BACKGROUND
  • 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: 19452619BACKGROUND
  • 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: 15759949BACKGROUND
  • 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: 23221583BACKGROUND
  • 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: 18403245BACKGROUND
  • 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: 22573523BACKGROUND
  • 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: 22150039BACKGROUND
  • 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.

    PMID: 24911455BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Noha Foad, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 6, 2018

Study Start

August 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

February 6, 2024

Record last verified: 2020-05

Locations