Rheumatoid ArthritisNCT04486027
Can Cytokines be Used as an Activation Marker
An observational study of Rheumatoid Arthritis, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2017to 15 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Healthy individuals and Rheumatoid Arthritis patients meeting American College of Rheumatology (ACR) RA remission criteria.
Who cannot join
- Smoking, Using Disease-Modifying Anti-Rheumatic Drugs (DMARD) and/or anti-inflammatory drugs other than cortisol and methotrexate, Receiving chemotherapy, Being hypothyroid
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Cytokines be Used as an Activation Marker in Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- c reactive protein, Erythrocyte sedimentation rate, DAS-28, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein
Inflammatory biomarker
Measured: up to 24 months
Erythrocyte sedimentation rate
Inflammatory biomarker
Measured: up to 24 months
TNF alpha
Cytokine
Measured: up to 24 months
DAS 28
Disease activity scores
Measured: up to 24 months
IL 1beta
Cytokine
Measured: up to 24 months
IL 10
Cytokine
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start5 Apr 2017
- Primary completion1 Jun 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Nalbant, Maltepe University
- Investigators
- Selim Nalbant, Prof, Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486027
- Sponsor's protocol ID
- 2017/900/19
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27916980Deane 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.
PubMed 20597112Pratt 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.
PubMed 25481556
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cytokines be Used as an Activation Marker in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04486027
- Acronym / sponsor ID
- 2017/900/19
- Conditions
- Rheumatoid Arthritis
- Keywords
- c reactive protein, Erythrocyte sedimentation rate, DAS-28, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Healthy individuals and Rheumatoid Arthritis patients meeting American College of Rheumatology (ACR) RA remission criteria.
Key exclusion criteria (2 listed)
- Smoking, Using Disease-Modifying Anti-Rheumatic Drugs (DMARD) and/or anti-inflammatory drugs other than cortisol and methotrexate, Receiving chemotherapy, Being hypothyroid
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
C Reactive Protein
Time frame: up to 24 months
Inflammatory biomarker
Erythrocyte sedimentation rate
Time frame: up to 24 months
Inflammatory biomarker
TNF alpha
Time frame: up to 24 months
Cytokine
DAS 28
Time frame: up to 24 months
Disease activity scores
IL 1beta
Time frame: up to 24 months
Cytokine
IL 10
Time frame: up to 24 months
Cytokine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 27916980Malmstrom 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.
- Background: PubMed 20597112Deane 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.
- Background: PubMed 25481556Pratt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Nalbant, Prof principal investigator
Maltepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Reactive Protein (time frame: up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486027, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.