MedPath

Can Cytokines be Used as an Activation Marker

Completed
Conditions
Rheumatoid Arthritis
Registration Number
NCT04486027
Lead Sponsor
Maltepe University
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.

Detailed Description

Aims: The etiopathogenesis of Rheumatoid Arthritis (RA) is not clearly understood. However, role of the cytokines takes an important part of this mechanism. The investigators aimed to bring a new approach to the concept of 'remission' in patients with RA.

Background: 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. It is an interesting pathophysiological process, the exact cause of which is still unknown, with many environmental, genetic and potentially undiscovered possible factors in a chaotic manner.

Objective: In this prospective 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. Disease activity score-28 (DAS-28) was calculated in active RA and RA in remission.

Methods: This study included 20 healthy volunteers, 20 remission patients with RA and 20 active RA patients. Venous blood samples were collected from patients in both healthy and RA groups.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
C Reactive Proteinup to 24 months

Inflammatory biomarker

Erythrocyte sedimentation rateup to 24 months

Inflammatory biomarker

TNF alphaup to 24 months

Cytokine

DAS 28up to 24 months

Disease activity scores

IL 1betaup to 24 months

Cytokine

IL 10up to 24 months

Cytokine

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Selim Nalbant

🇹🇷

Istanbul, Turkey

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