Clinical trial NCT04486027: Can Cytokines be Used as an Activation Marker
Official title: Can Cytokines be Used as an Activation Marker in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: c reactive protein
Erythrocyte sedimentation rate
DAS-28
Rheumatoid Arthritis
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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

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.

Eligibility criteria: 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

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Primary outcomes:
measure: C Reactive Protein
timeFrame: up to 24 months
measure: Erythrocyte sedimentation rate
timeFrame: up to 24 months
measure: TNF alpha
timeFrame: up to 24 months
measure: DAS 28
timeFrame: up to 24 months
measure: IL 1beta
timeFrame: up to 24 months
measure: IL 10
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Selim Nalbant
Study officials:
affiliation: Maltepe University
name: Selim Nalbant, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.