NCT04486027

Brief Summary

RA is a chronic, autoimmune, inflammatory disease that involves small joints in the form of symmetrical polyarthritis and progresses with exacerbations and remissions. Pain, swelling, tenderness and morning stiffness are typical of the joints involved. Although it is approached as a primary joint disease, a wide variety of extra-articular involvements may also occur. In this cross sectional study sedimentation rate (ESR), C- Reactive protein (CRP), Tumor necrosis factor (TNF)-α, soluble-TNF-α receptor (TNF-R), Interleukin (IL)-1B and IL-10 were measured in three groups which were healthy volunteers, patients with RA in active period, and patients with RA in remission. TNF-R can be the main pathophysiological factor and a marker showing activation. TNF-R can be very important in revealing the effect of TNF on the disease and the value of this effect in the treatment and ensuring the follow-up of the disease with CRP instead of ESR in activation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

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

Study Start

First participant enrolled

April 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

July 13, 2020

Last Update Submit

July 21, 2020

Conditions

Rheumatoid Arthritis

Keywords

c reactive proteinErythrocyte sedimentation rateDAS-28Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

  • C Reactive Protein

    Inflammatory biomarker

    up to 24 months

  • Erythrocyte sedimentation rate

    Inflammatory biomarker

    up to 24 months

  • TNF alpha

    Cytokine

    up to 24 months

  • DAS 28

    Disease activity scores

    up to 24 months

  • IL 1beta

    Cytokine

    up to 24 months

  • IL 10

    Cytokine

    up to 24 months

Study Arms (3)

Healthy

Healthy individuals not smoking, not using Disease-Modifying Anti-Rheumatic Drugs (DMARD) and/or anti-inflammatory drugs other than cortisol and methotrexate, not receiving chemotherapy, not being hypothyroidic

Active Rheumatoid Arthritis

Active Rheumatoid Arthritis meeting American College of Rheumatology (ACR) RA remission criteria

Rheumatoid Arthritis in remission

Rheumatoid Arthritis in remission meeting American College of Rheumatology (ACR) RA remission criteria

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study included 20 healthy volunteers, 20 remission patients with RA and 20 active patients with RA. Patients who met the study criteria among patients with RA who applied to Maltepe University Medical Faculty Hospital Internal Medicine-Rheumatology Outpatient Clinic were included in the study

You may qualify if:

  • Healthy individuals and Rheumatoid Arthritis patients meeting American College of Rheumatology (ACR) RA remission criteria.

You may not qualify if:

  • Smoking, Using Disease-Modifying Anti-Rheumatic Drugs (DMARD) and/or anti-inflammatory drugs other than cortisol and methotrexate, Receiving chemotherapy, Being hypothyroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selim Nalbant

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Malmstrom V, Catrina AI, Klareskog L. The immunopathogenesis of seropositive rheumatoid arthritis: from triggering to targeting. Nat Rev Immunol. 2017 Jan;17(1):60-75. doi: 10.1038/nri.2016.124. Epub 2016 Dec 5.

    PMID: 27916980BACKGROUND

  • Deane KD, O'Donnell CI, Hueber W, Majka DS, Lazar AA, Derber LA, Gilliland WR, Edison JD, Norris JM, Robinson WH, Holers VM. The number of elevated cytokines and chemokines in preclinical seropositive rheumatoid arthritis predicts time to diagnosis in an age-dependent manner. Arthritis Rheum. 2010 Nov;62(11):3161-72. doi: 10.1002/art.27638.

    PMID: 20597112BACKGROUND

  • Pratt AG, Isaacs JD. Seronegative rheumatoid arthritis: pathogenetic and therapeutic aspects. Best Pract Res Clin Rheumatol. 2014 Aug;28(4):651-9. doi: 10.1016/j.berh.2014.10.016. Epub 2014 Nov 18.

    PMID: 25481556BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Selim Nalbant, Prof

    Maltepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 24, 2020

Study Start

April 5, 2017

Primary Completion

June 1, 2018

Study Completion

December 15, 2018

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)