Rheumatoid ArthritisNCT06540573
The Relationship Between Serum Chemokine Ligand 21 (CCL-21) Level and Disease Activity
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by Gaziosmanpasa Research and Education Hospital.
Trial summary
Rheumatoid arthritis (RA) is a chronic systemic disease characterized by the development of new capillaries involved in the infiltration of inflammatory cells causing synovial hyperplasia and progressive destruction of cartilage and bone.Osteoarthritis (OA) is a degenerative joint disease that involves articular… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- Laboratory tests (examination), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and The Disease Activity Score28 (DAS28)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2024to 30 Nov 2024
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Selection of all patient and healthy control volunteers was carried out at Gaziosmanpasa Training and Research Hospital Physical Medicine and Rehabilitation Department; It was conducted consecutively from rheumatology outpatient clinics. 20 healthy volunteers, 20 patients diagnosed with Osteoarthritis (meeting the American College of Rheumatology (ACR) criteria), and 20 patients diagnosed with Rheumatoid Arthritis (meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria) will be included in the study. Written and verbal consent will be obtained from all individuals included in the study.
Who may be able to join
- 20 RA patients, 20 Osteoarthritis patients and 20 healthy volunteers between the ages of 16-60.
Who cannot join
- Age < 16 years,
- Systemic Disorders (Diabetes, Hematological diseases (coagulopathies), serious cardiovascular diseases, chronic liver and kidney disease or malignancy.)
- Patients suffering from infectious disorders (septic arthritis, viral arthritis, fungal arthritis and other rheumatic diseases such as spondyloarthropathies, systemic lupus erythematosus or dermatomyositis and others.)
- Individuals with other autoimmune diseases, malignancy, cardiac or neurological deficits, end-stage organ failure and other conditions that may affect the serum level of CCL21, such as diabetes mellitus, concomitant inflammatory disease (acute infection or chronic inflammatory state), coronary artery disease and hepatitis, were excluded from the study. was left
- Lymphadenopathies
- OA patients who received intra-articular injection or systemic glucocorticoid therapy within 3 months were excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship Between Serum Chemokine Ligand 21 (CCL-21) Level and Disease Activity in Patients With Rheumatoid Arthritis and Osteoarthritis
Rheumatoid arthritis (RA) is a chronic systemic disease characterized by the development of new capillaries involved in the infiltration of inflammatory cells causing synovial hyperplasia and progressive destruction of cartilage and bone.Osteoarthritis (OA) is a degenerative joint disease that involves articular cartilage and other intra-articular structures.Although the pathological mechanisms involved in OA and RA are different, the onset and progression of both diseases are associated with inflammation, immune mechanisms and metabolic factors.C-C Motif Chemokine Ligand 21 (CCL21) is a CCR7-binding chemokine that plays an important role by modulating the circulation of T cells and dendritic cells in lymphoid and peripheral organs (9). Ligation of CCL21 in RA fibroblasts and macrophages induced the production of proangiogenic factors such as VEGF, Ang-1, and IL-8, suggesting that CCL21 plays an indirect role in RA angiogenesis.The aim of our study is to evaluate the serum levels of CCL21 in RA and OA patients by comparing them with healthy controls. In addition, the aim is to examine the correlation of serum CCL21 with disease degree/severity in both diseases and to determine whether it can be a biomarker of the disease state.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic disease characterized by the development of new capillaries involved in the infiltration of inflammatory cells causing synovial hyperplasia and progressive destruction of cartilage and bone. The synovial tissue layer consists of macrophages and fibroblasts, which have profound effects on the destructive process in RA through the production of pro-inflammatory cytokines, chemokines and pro-angiogenic factors (2,3). Osteoarthritis (OA) is a degenerative joint disease that involves articular cartilage and other intra-articular structures (4). OA leads to pain, stiffness, decreased joint function (5), and ultimately disability (6). Although the pathological mechanisms involved in OA and RA are different, the onset and progression of both diseases are associated with inflammation, immune mechanisms and metabolic factors (7,8). C-C Motif Chemokine Ligand 21 (CCL21) is a CCR7-binding chemokine that plays an important role by modulating the circulation of T cells and dendritic cells in lymphoid and peripheral organs (9). Ligation of CCL21 in RA fibroblasts and macrophages induced the production of proangiogenic factors such as VEGF, Ang-1, and IL-8, suggesting that CCL21 plays an indirect role in RA angiogenesis ( 10 ).
We determined that CCL21-mediated RA arthritis extends joint inflammation to bone erosion by coupling the differentiation of M1 macrophages with Th17 cells. Disease progression is further exacerbated by CCL21-induced neovascularization. We conclude that CCL21 is an attractive new target for the treatment of RA, as blocking its function can abolish erosive arthritis modulated by M1 macrophages and Th17 cell crosstalk. In short, CCL21 is a pleiotropic chemokine that shapes many aspects of RA pathology. We have not found a study that examined CCL21 blood serum levels in RA and OA patients and healthy controls and evaluated whether there is a relationship between CCL21 and these diseases.
The aim of our study is to evaluate the serum levels of CCL21 in RA and OA patients by comparing them with healthy controls. In addition, the aim is to examine the correlation of serum CCL21 with disease degree/severity in both diseases and to determine whether it can be a biomarker of the disease state.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- Laboratory tests (examination), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, The Disease Activity Score28 (DAS28), Patient global assessment (PGA), Physician global assessment (PhGA)
- Keywords
- C-C Motif Chemokine Ligand 21, Rheumatoid Arthritis, Osteoarthritis, Disease severity
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tests (examination)Diagnostic test
Laboratory tests (examination) to be performed include complete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver function tests and kidney function tests; rheumatoid factor (RF), anti-cyclic citrullinated peptide antibody (anti-CCP antibody) and C-C Motif Chemokine Ligand 21 (CCL21).
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) IndexDiagnostic test
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) This questionnaire is used to assess the health status of osteoarthritis patients introduced in 1988 (13). It is consisted of 33 items which evaluates the health and function of the patient from various aspects including: clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions).The test questions are scored on a scale of 0-4, which correspond to: None(0),Mild (1),Moderate (2),Severe(3),and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The Disease Activity Score28 (DAS28)Diagnostic test
The Disease Activity Score (DAS) was created as a numerical tool for quantifying and assessing disease activity in rheumatoid arthritis (RA).The DAS28 (Disease Activity Score using 28 joint counts) was developed from the original DAS (Disease Activity Score).The DAS28 evaluates the disease activity by assessing the number of tender and swollen joints in a patient. Specifically, it considers 28 joints. The DAS28 also takes into account a blood marker of inflammation, typically the erythrocyte sedimentation rate (ESR) or the C-reactive protein (CRP) level.A patient with a DAS28 score of less than 2.6 is in remission; a score greater than or equal to 2.6 and less than 3.1 indicates low activity; a score greater than or equal to 3.1 and <5.1 indicates moderate activity and a score 5.1 or more indicates high activity
Patient global assessment (PGA)Diagnostic test
Patient global assessment (PGA) of disease activity will be reported by patients. PGA was developed in the late 1970s and was initially designed for the measurement of self-assessed pain in RA [8], although it has since been used to evaluate RA more globally. It is interesting to note that the way PGA is used in clinical practice covers, in fact, two very different concepts, one related to global health and the other to overall disease activity. They are both usually used under the heading of PGA without further specification for which is being assessed.
Physician global assessment (PhGA)Diagnostic test
Physician global assessment (PhGA)of disease activity will be reported by the physician.The Physician Global Assessment (PhGA) of treatment response measures the overall response to treatment as assessed by the physician. The PhGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. PhGA is a simple instrument and the result is easily understood. However, assigning a score for PhGA requires a very detailed evaluation. To perform this assessment a physician/health care provider would use extensive data from every aspect of ICF.
Health Assessment Questionnaire (HAQ)Diagnostic test
Functional impairment will be assessed with the Health Assessment Questionnaire (HAQ). It is a self-assessment tool used to measure functional ability in eight different areas: rising, dressing and grooming, hygiene, eating, walking, reach, grip, and activities of independent living. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The 8 category scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). If the questionnaire is slightly changed to reflect a certain disease, this does not affect the respective scoring.Scores 0-1 indicates mild to moderate disability, 1-2 indicates moderate to severe disability, and 2-3 indicates severe to very severe disability.
Clinical disease activity index (CDAI)Diagnostic test
Clinical Disease Activity Index (CDAI) is a composite index (without acute-phase reactant) for assessing disease activity. CDAI is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76
The Simplified Disease Activity Index (SDAI)Diagnostic test
The Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is a scoring system that has been validated in both research and clinical settings. It has been shown to have the highest sensitivity and specificity for predicting a physicians' decisions to change DMARD therapy when compared to other scores.Remission is defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26. Response to therapy is considered moderate if SDAI decreases by ≥7 and major if decreases by ≥17
Knee RadiographyDiagnostic test
Knee osteoarthritis (gonarthrosis) will be evaluated using Kellgren-Lawrence (KL) staging on direct radiographs (anteroposterior and lateral views).Numerous variations of the Kellgren and Lawrence classification system have been used in research. Grade 0 (none): definite absence of x-ray changes of osteoarthritis. Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping.Grade 2 (minimal): definite osteophytes and possible joint space narrowing. Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends Grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends. Osteoarthritis is deemed present at grade 2 although of minimal severity
| Study group | Role | What they receive |
|---|---|---|
| Patients who were diagnosed with osteoarthritis and applied to outpatient clinic | Patients diagnosed with osteoarthritis (meeting the American College of Rheumatology (ACR) criteria Receives: Diagnostic Test: Laboratory tests (examination); Diagnostic Test: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; Diagnostic Test: Patient global assessment (PGA); Diagnostic Test: Physician global assessment (PhGA); Diagnostic Test: Health Assessment Questionnaire (HAQ); Diagnostic Test: Knee Radiography | |
| Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic | Patients diagnosed with rheumatoid arthritis (meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria Receives: Diagnostic Test: Laboratory tests (examination); Diagnostic Test: The Disease Activity Score28 (DAS28); Diagnostic Test: Patient global assessment (PGA); Diagnostic Test: Physician global assessment (PhGA); Diagnostic Test: Health Assessment Questionnaire (HAQ); Diagnostic Test: Clinical disease activity index (CDAI); Diagnostic Test: The Simplified Disease Activity Index (SDAI) | |
| Healthy volunteers | Healthy who were volunteers applied to the physical treatment and rehabilitation outpatient clinic Receives: Diagnostic Test: Laboratory tests (examination); Diagnostic Test: Health Assessment Questionnaire (HAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Disease Activity Score28 (DAS28)
The Disease Activity Score (DAS) was created as a numerical tool for quantifying and assessing disease activity in rheumatoid arthritis (RA).The DAS28 (Disease Activity Score using 28 joint counts) was developed from the original DAS (Disease Activity Score).The DAS28 evaluates the disease activity by assessing the number of tender and swollen joints in a patient. Specifically, it considers 28 joints. The DAS28 also takes into account a blood marker of inflammation, typically the erythrocyte sedimentation rate (ESR) or the C-reactive protein (CRP) level.A patient with a DAS28 score of less than 2.6 is in remission; a score greater than or equal to 2.6 and less than 3.1 indicates low activity; a score greater than or equal to 3.1 and <5.1 indicates moderate activity and a score 5.1 or more indicates high activity
Measured: Within 1 week of applying to outpatient clinic
Patient global assessment (PGA)
Patient global assessment (PGA) of disease activity will be reported by patients. PGA was developed in the late 1970s and was initially designed for the measurement of self-assessed pain in RA [8], although it has since been used to evaluate RA more globally. It is interesting to note that the way PGA is used in clinical practice covers, in fact, two very different concepts, one related to global health and the other to overall disease activity. They are both usually used under the heading of PGA without further specification for which is being assessed.
Measured: Within 1 week of applying to outpatient clinic
Physician global assessment (PhGA)
Physician global assessment (PhGA)of disease activity will be reported by the physician.The Physician Global Assessment (PhGA) of treatment response measures the overall response to treatment as assessed by the physician. The PhGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. PhGA is a simple instrument and the result is easily understood. However, assigning a score for PhGA requires a very detailed evaluation. To perform this assessment a physician/health care provider would use extensive data from every aspect of ICF.
Measured: Within 1 week of applying to outpatient clinic
Health Assessment Questionnaire (HAQ)
Functional impairment will be assessed with the Health Assessment Questionnaire (HAQ). It is a self-assessment tool used to measure functional ability in eight different areas: rising, dressing and grooming, hygiene, eating, walking, reach, grip, and activities of independent living. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The 8 category scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). If the questionnaire is slightly changed to reflect a certain disease, this does not affect the respective scoring.Scores 0-1 indicates mild to moderate disability, 1-2 indicates moderate to severe disability, and 2-3 indicates severe to very severe disability.
Measured: Within 1 week of applying to outpatient clinic
Clinical disease activity index (CDAI)
Clinical Disease Activity Index (CDAI) is a composite index (without acute-phase reactant) for assessing disease activity. CDAI is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76
Measured: Within 1 week of applying to outpatient clinic
Simplified Disease Activity Index
The Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is a scoring system that has been validated in both research and clinical settings. It has been shown to have the highest sensitivity and specificity for predicting a physicians' decisions to change DMARD therapy when compared to other scores.Remission is defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26. Response to therapy is considered moderate if SDAI decreases by ≥7 and major if decreases by ≥17
Measured: Within 1 week of applying to outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start12 Aug 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ismail Dag, Study chair, Eyup Sultan State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540573
- Sponsor's protocol ID
- 450
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li G, Zhao J, Li B, Ma J, Zhao Q, Wang X, Lv Z, Li K, Du Z, Ma X, Liu J. Associations between CCL21 gene polymorphisms and susceptibility to rheumatoid arthritis: a meta-analysis. Rheumatol Int. 2017 Oct;37(10):1673-1681. doi: 10.1007/s00296-017-3784-4. Epub 2017 Aug 10.
PubMed 28799100Van Raemdonck K, Umar S, Palasiewicz K, Volkov S, Volin MV, Arami S, Chang HJ, Zanotti B, Sweiss N, Shahrara S. CCL21/CCR7 signaling in macrophages promotes joint inflammation and Th17-mediated osteoclast formation in rheumatoid arthritis. Cell Mol Life Sci. 2020 Apr;77(7):1387-1399. doi: 10.1007/s00018-019-03235-w. Epub 2019 Jul 24.
PubMed 31342120
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Chemokine Ligand 21 (CCL-21) Level and Disease Activity in Patients With Rheumatoid Arthritis and Osteoarthritis
- ClinicalTrials.gov ID
- NCT06540573
- Acronym / sponsor ID
- 450
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Keywords
- C-C Motif Chemokine Ligand 21, Rheumatoid Arthritis, Osteoarthritis, Disease severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 12 Aug 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 6 Aug 2024 (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.
Rheumatoid arthritis (RA) is a chronic systemic disease characterized by the development of new capillaries involved in the infiltration of inflammatory cells causing synovial hyperplasia and progressive destruction of cartilage and bone.Osteoarthritis (OA) is a degenerative joint disease that involves articular cartilage and other intra-articular structures.Although the pathological mechanisms involved in OA and RA are different, the onset and progression of both diseases are associated with inflammation, immune mechanisms and metabolic factors.C-C Motif Chemokine Ligand 21 (CCL21) is a CCR7-binding chemokine that plays an important role by modulating the circulation of T cells and dendritic cells in lymphoid and peripheral organs (9). Ligation of CCL21 in RA fibroblasts and macrophages induced the production of proangiogenic factors such as VEGF, Ang-1, and IL-8, suggesting that CCL21 plays an indirect role in RA angiogenesis.The aim of our study is to evaluate the serum levels of CCL21 in RA and OA patients by comparing them with healthy controls. In addition, the aim is to examine the correlation of serum CCL21 with disease degree/severity in both diseases and to determine whether it can be a biomarker of the disease state.
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic disease characterized by the development of new capillaries involved in the infiltration of inflammatory cells causing synovial hyperplasia and progressive destruction of cartilage and bone. The synovial tissue layer consists of macrophages and fibroblasts, which have profound effects on the destructive process in RA through the production of pro-inflammatory cytokines, chemokines and pro-angiogenic factors (2,3). Osteoarthritis (OA) is a degenerative joint disease that involves articular cartilage and other intra-articular structures (4). OA leads to pain, stiffness, decreased joint function (5), and ultimately disability (6). Although the pathological mechanisms involved in OA and RA are different, the onset and progression of both diseases are associated with inflammation, immune mechanisms and metabolic factors (7,8). C-C Motif Chemokine Ligand 21 (CCL21) is a CCR7-binding chemokine that plays an important role by modulating the circulation of T cells and dendritic cells in lymphoid and peripheral organs (9). Ligation of CCL21 in RA fibroblasts and macrophages induced the production of proangiogenic factors such as VEGF, Ang-1, and IL-8, suggesting that CCL21 plays an indirect role in RA angiogenesis ( 10 ).
We determined that CCL21-mediated RA arthritis extends joint inflammation to bone erosion by coupling the differentiation of M1 macrophages with Th17 cells. Disease progression is further exacerbated by CCL21-induced neovascularization. We conclude that CCL21 is an attractive new target for the treatment of RA, as blocking its function can abolish erosive arthritis modulated by M1 macrophages and Th17 cell crosstalk. In short, CCL21 is a pleiotropic chemokine that shapes many aspects of RA pathology. We have not found a study that examined CCL21 blood serum levels in RA and OA patients and healthy controls and evaluated whether there is a relationship between CCL21 and these diseases.
The aim of our study is to evaluate the serum levels of CCL21 in RA and OA patients by comparing them with healthy controls. In addition, the aim is to examine the correlation of serum CCL21 with disease degree/severity in both diseases and to determine whether it can be a biomarker of the disease state.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who were diagnosed with osteoarthritis and applied to outpatient clinic | – | Diagnostic Test: Laboratory tests (examination), Diagnostic Test: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, Diagnostic Test: Patient global assessment (PGA), Diagnostic Test: Physician global assessment (PhGA), Diagnostic Test: Health Assessment Questionnaire (HAQ), Diagnostic Test: Knee RadiographyPatients diagnosed with osteoarthritis (meeting the American College of Rheumatology (ACR) criteria |
| Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic | – | Diagnostic Test: Laboratory tests (examination), Diagnostic Test: The Disease Activity Score28 (DAS28), Diagnostic Test: Patient global assessment (PGA), Diagnostic Test: Physician global assessment (PhGA), Diagnostic Test: Health Assessment Questionnaire (HAQ), Diagnostic Test: Clinical disease activity index (CDAI), Diagnostic Test: The Simplified Disease Activity Index (SDAI)Patients diagnosed with rheumatoid arthritis (meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria |
| Healthy volunteers | – | Diagnostic Test: Laboratory tests (examination), Diagnostic Test: Health Assessment Questionnaire (HAQ)Healthy who were volunteers applied to the physical treatment and rehabilitation outpatient clinic |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Selection of all patient and healthy control volunteers was carried out at Gaziosmanpasa Training and Research Hospital Physical Medicine and Rehabilitation Department; It was conducted consecutively from rheumatology outpatient clinics. 20 healthy volunteers, 20 patients diagnosed with Osteoarthritis (meeting the American College of Rheumatology (ACR) criteria), and 20 patients diagnosed with Rheumatoid Arthritis (meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria) will be included in the study. Written and verbal consent will be obtained from all individuals included in the study.
Key inclusion criteria (1 listed)
- 20 RA patients, 20 Osteoarthritis patients and 20 healthy volunteers between the ages of 16-60.
Key exclusion criteria (6 listed)
- Age < 16 years,
- Systemic Disorders (Diabetes, Hematological diseases (coagulopathies), serious cardiovascular diseases, chronic liver and kidney disease or malignancy.)
- Patients suffering from infectious disorders (septic arthritis, viral arthritis, fungal arthritis and other rheumatic diseases such as spondyloarthropathies, systemic lupus erythematosus or dermatomyositis and others.)
- Individuals with other autoimmune diseases, malignancy, cardiac or neurological deficits, end-stage organ failure and other conditions that may affect the serum level of CCL21, such as diabetes mellitus, concomitant inflammatory disease (acute infection or chronic inflammatory state), coronary artery disease and hepatitis, were excluded from the study. was left
- Lymphadenopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tests (examination)Laboratory tests (examination) to be performed include complete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver function tests and kidney function tests; rheumatoid factor (RF), anti-cyclic citrullinated peptide antibody (anti-CCP antibody) and C-C Motif Chemokine Ligand 21 (CCL21). | Diagnostic test | Healthy volunteers, Patients who were diagnosed with osteoarthritis and applied to outpatient clinic, Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) IndexWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) This questionnaire is used to assess the health status of osteoarthritis patients introduced in 1988 (13). It is consisted of 33 items which evaluates the health and function of the patient from various aspects including: clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions).The test questions are scored on a scale of 0-4, which correspond to: None(0),Mild (1),Moderate (2),Severe(3),and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Diagnostic test | Patients who were diagnosed with osteoarthritis and applied to outpatient clinic |
| The Disease Activity Score28 (DAS28)The Disease Activity Score (DAS) was created as a numerical tool for quantifying and assessing disease activity in rheumatoid arthritis (RA).The DAS28 (Disease Activity Score using 28 joint counts) was developed from the original DAS (Disease Activity Score).The DAS28 evaluates the disease activity by assessing the number of tender and swollen joints in a patient. Specifically, it considers 28 joints. The DAS28 also takes into account a blood marker of inflammation, typically the erythrocyte sedimentation rate (ESR) or the C-reactive protein (CRP) level.A patient with a DAS28 score of less than 2.6 is in remission; a score greater than or equal to 2.6 and less than 3.1 indicates low activity; a score greater than or equal to 3.1 and <5.1 indicates moderate activity and a score 5.1 or more indicates high activity | Diagnostic test | Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Patient global assessment (PGA)Patient global assessment (PGA) of disease activity will be reported by patients. PGA was developed in the late 1970s and was initially designed for the measurement of self-assessed pain in RA [8], although it has since been used to evaluate RA more globally. It is interesting to note that the way PGA is used in clinical practice covers, in fact, two very different concepts, one related to global health and the other to overall disease activity. They are both usually used under the heading of PGA without further specification for which is being assessed. | Diagnostic test | Patients who were diagnosed with osteoarthritis and applied to outpatient clinic, Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Physician global assessment (PhGA)Physician global assessment (PhGA)of disease activity will be reported by the physician.The Physician Global Assessment (PhGA) of treatment response measures the overall response to treatment as assessed by the physician. The PhGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. PhGA is a simple instrument and the result is easily understood. However, assigning a score for PhGA requires a very detailed evaluation. To perform this assessment a physician/health care provider would use extensive data from every aspect of ICF. | Diagnostic test | Patients who were diagnosed with osteoarthritis and applied to outpatient clinic, Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Health Assessment Questionnaire (HAQ)Functional impairment will be assessed with the Health Assessment Questionnaire (HAQ). It is a self-assessment tool used to measure functional ability in eight different areas: rising, dressing and grooming, hygiene, eating, walking, reach, grip, and activities of independent living. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The 8 category scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). If the questionnaire is slightly changed to reflect a certain disease, this does not affect the respective scoring.Scores 0-1 indicates mild to moderate disability, 1-2 indicates moderate to severe disability, and 2-3 indicates severe to very severe disability. | Diagnostic test | Healthy volunteers, Patients who were diagnosed with osteoarthritis and applied to outpatient clinic, Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Clinical disease activity index (CDAI)Clinical Disease Activity Index (CDAI) is a composite index (without acute-phase reactant) for assessing disease activity. CDAI is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76 | Diagnostic test | Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| The Simplified Disease Activity Index (SDAI)The Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is a scoring system that has been validated in both research and clinical settings. It has been shown to have the highest sensitivity and specificity for predicting a physicians' decisions to change DMARD therapy when compared to other scores.Remission is defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26. Response to therapy is considered moderate if SDAI decreases by ≥7 and major if decreases by ≥17 | Diagnostic test | Patients who were diagnosed with rheumatoid arthritis and applied to outpatient clinic |
| Knee RadiographyKnee osteoarthritis (gonarthrosis) will be evaluated using Kellgren-Lawrence (KL) staging on direct radiographs (anteroposterior and lateral views).Numerous variations of the Kellgren and Lawrence classification system have been used in research. Grade 0 (none): definite absence of x-ray changes of osteoarthritis. Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping.Grade 2 (minimal): definite osteophytes and possible joint space narrowing. Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends Grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends. Osteoarthritis is deemed present at grade 2 although of minimal severity | Diagnostic test | Patients who were diagnosed with osteoarthritis and applied to outpatient clinic |
Primary outcome
The Disease Activity Score28 (DAS28)
Time frame: Within 1 week of applying to outpatient clinic
The Disease Activity Score (DAS) was created as a numerical tool for quantifying and assessing disease activity in rheumatoid arthritis (RA).The DAS28 (Disease Activity Score using 28 joint counts) was developed from the original DAS (Disease Activity Score).The DAS28 evaluates the disease activity by assessing the number of tender and swollen joints in a patient. Specifically, it considers 28 joints. The DAS28 also takes into account a blood marker of inflammation, typically the erythrocyte sedimentation rate (ESR) or the C-reactive protein (CRP) level.A patient with a DAS28 score of less than 2.6 is in remission; a score greater than or equal to 2.6 and less than 3.1 indicates low activity; a score greater than or equal to 3.1 and <5.1 indicates moderate activity and a score 5.1 or more indicates high activity
Patient global assessment (PGA)
Time frame: Within 1 week of applying to outpatient clinic
Patient global assessment (PGA) of disease activity will be reported by patients. PGA was developed in the late 1970s and was initially designed for the measurement of self-assessed pain in RA [8], although it has since been used to evaluate RA more globally. It is interesting to note that the way PGA is used in clinical practice covers, in fact, two very different concepts, one related to global health and the other to overall disease activity. They are both usually used under the heading of PGA without further specification for which is being assessed.
Physician global assessment (PhGA)
Time frame: Within 1 week of applying to outpatient clinic
Physician global assessment (PhGA)of disease activity will be reported by the physician.The Physician Global Assessment (PhGA) of treatment response measures the overall response to treatment as assessed by the physician. The PhGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. PhGA is a simple instrument and the result is easily understood. However, assigning a score for PhGA requires a very detailed evaluation. To perform this assessment a physician/health care provider would use extensive data from every aspect of ICF.
Health Assessment Questionnaire (HAQ)
Time frame: Within 1 week of applying to outpatient clinic
Functional impairment will be assessed with the Health Assessment Questionnaire (HAQ). It is a self-assessment tool used to measure functional ability in eight different areas: rising, dressing and grooming, hygiene, eating, walking, reach, grip, and activities of independent living. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The 8 category scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). If the questionnaire is slightly changed to reflect a certain disease, this does not affect the respective scoring.Scores 0-1 indicates mild to moderate disability, 1-2 indicates moderate to severe disability, and 2-3 indicates severe to very severe disability.
Clinical disease activity index (CDAI)
Time frame: Within 1 week of applying to outpatient clinic
Clinical Disease Activity Index (CDAI) is a composite index (without acute-phase reactant) for assessing disease activity. CDAI is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76
Simplified Disease Activity Index
Time frame: Within 1 week of applying to outpatient clinic
The Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is a scoring system that has been validated in both research and clinical settings. It has been shown to have the highest sensitivity and specificity for predicting a physicians' decisions to change DMARD therapy when compared to other scores.Remission is defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26. Response to therapy is considered moderate if SDAI decreases by ≥7 and major if decreases by ≥17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 28799100Li G, Zhao J, Li B, Ma J, Zhao Q, Wang X, Lv Z, Li K, Du Z, Ma X, Liu J. Associations between CCL21 gene polymorphisms and susceptibility to rheumatoid arthritis: a meta-analysis. Rheumatol Int. 2017 Oct;37(10):1673-1681. doi: 10.1007/s00296-017-3784-4. Epub 2017 Aug 10.
- Results publication: PubMed 31342120Van Raemdonck K, Umar S, Palasiewicz K, Volkov S, Volin MV, Arami S, Chang HJ, Zanotti B, Sweiss N, Shahrara S. CCL21/CCR7 signaling in macrophages promotes joint inflammation and Th17-mediated osteoclast formation in rheumatoid arthritis. Cell Mol Life Sci. 2020 Apr;77(7):1387-1399. doi: 10.1007/s00018-019-03235-w. Epub 2019 Jul 24.
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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.
Ismail Dag study chair
Eyup Sultan State Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by Gaziosmanpasa Research and Education Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deniz Oke, MD (+90 532 430 69 50, dr_denizoke@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Disease Activity Score28 (DAS28) (time frame: Within 1 week of applying to outpatient clinic). 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 NCT06540573, which also lists 2 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 6 Aug 2024.