The Relationship Between Serum Chemokine Ligand 21 (CCL-21) Level and Disease Activity
NCT Number: NCT06540573
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis|Osteoarthritis
Interventions: DIAGNOSTIC_TEST: Laboratory tests (examination)|DIAGNOSTIC_TEST: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index|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)|DIAGNOSTIC_TEST: Knee Radiography
Sponsor: Gaziosmanpasa Research and Education Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2024-11-30

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 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.

Primary Outcome Measures: 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, 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., 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., 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., 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, 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, Within 1 week of applying to outpatient clinic