Uromodulin in Rheumatoid Arthritis

NCT03972098 | Completed

• 1 other identifier: Gaziosmanpasa Hospital
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the levels of uromodulin in rheumatoid arthritis (RA) and to investigate whether it was correlated with baseline clinical characteristics. In addition CKD epi,MDRD,urine microalbuminuria,pH,serum urea, creatinine,CRP (C-Reactive protein) were measured.The participants consist of ; %68 patients,% 32 control group.

Conditions

Rheumatoid Arthritis

Keywords

uromodulin

Outcome Measures

Primary Outcomes (6)

• Patients with rheumatoid arthritis

  The diagnosis of RA was based on the criteria the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) in 2010. Patients selected 1. have at least 1 joint with definite clinical synovitis (swelling) 2. with the synovitis not better explained by another disease Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of \>6/10 is needed for classification of a patient as having definite RA)

  1 day

• A.joint involvement

  1 large joint (score 0) 2-10 large joints (score 1) 1-3 small joints (with or without involvement of large joints)#(score2) 4-10 small joints (with or without involvement of large joints)(score 3) 10 joints (at least 1 small joint) (score 5)

  1 day

• B.Serology (at least 1 test result is needed for classification)

  Negative RF and negative ACPA (Score 0) Low-positive RF or low-positive ACPA( anticitrullinated protein antibody) (score 2) High-positive RF(rheumatoid factor) or high-positive ACPA (score 3)

  1 day

• C.Acute-phase reactants (at least 1 test result is needed for classification)

  Normal CRP (C-reactive protein and normal) and normal ESR (erythrocyte sedimentation rate) (score 0) Abnormal CRP or abnormal ESR (score1)

  1 day

• D.Duration of symptoms

  \<6 weeks (score 0) \>6 weeks (score 1)

  1 day

• Uromodulin measure

  First urine sample taken in the morning

  1 day

Secondary Outcomes (7)

• CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)

  1 day

• MDRD (Modification of Diet in Renal Disease)

  1 day

• Urea measure

  1 day

• Creatinine measure

  1 day

• Sedimantation measure

  1 day

Study Arms (2)

ra patients

The diagnosis of RA was based on the criteria developed by the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) in 2010 \[8\]. A drug history was obtained from every patient. All non-steroidal anti-inflammatory medications and disease-modifying antirheumatic drugs prescribed during the year before enrollment in the study were recorded. criteria included systemic diseases (renal failure, hepatic insufficiency, diabetes mellitus, other collagen vascular diseases, history of smoking and consumption of alcohol.In order to eliminate the possibility of any systemic disease therefore we choose that our control group as young.

healthy control

healthy person, similar population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A drug history was obtained from every patient. All non-steroidal anti-inflammatory medications and disease-modifying antirheumatic drugs prescribed during the year before enrollment in the study were recorded. In order to eliminate the possibility of any systemic disease therefore we choose that our control group as young

You may qualify if:

• Patients who diagnosed of rheumatoid arthritis as criteria of ACR/EULAR 2010.
• All patients age range is 18-80 years.

You may not qualify if:

• Renal failure
• Hepatic insufficiency
• Diabetes mellitus
• Other collagen vascular diseases,
• History of smoking and consumption of alcohol

Sponsors & Collaborators

• neval aksoy: lead

Study Sites (1)

Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• neval aksoy, MD

  Sağlık Bilimleri Universty

  STUDY CHAIR

• lüfiye aytüre, MD

  sağlık Bilimleri Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Head of Urine Laboratory Department

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: June 3, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

TU (1)