An observational study in Rheumatoid Arthritis and Serum Albumin Low, sponsored by Assiut University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Assiut University · Observational
Rheumatoid arthritis is a chronic systemic inflammatory and autoimmune disease, characterized by disordered immunity, not regulated cytokines and inflammatory infiltration of the synovial joints. It is the most common inflammatory erosive poly arthritis affecting around 0.5-1% of the worldwide population which leads to joint damage and disability
The etiology of Rheumatoid arthritis is complex, it is established that the gene environmental interaction plays critical roles in the pathology of Rheumatoid arthritis, in addition to smoking, lifestyle, and hormones.
The lesion is mainly concentrated in the synovial tissue, cartilage, and bone. Inflammation is the primary cause of joint deformation and limited joint mobility in Rheumatoid arthritis patients. As the disease progresses, the risk of bone damage and cartilage destruction increases, leading to substantial disability.
The activity of the disease in Rheumatoid arthritis patients is assessed by clinical examination, laboratory tests and radio graphic assessment. Laboratory assessment of Rheumatoid arthritis activity is done routinely by measuring acute phase reactants such as an erythrocyte sedimentation rate and C-reactive protein, which are elevated in active Rheumatoid arthritis patients.
Albumin is the major plasma protein and its determination is used for the prognostic assessment of several diseases. It is a routine marker reflecting both nutritional status and systemic inflammation, and the synthesis of albumin can be suppressed by systematic inflammation and malnutrition.
It was reported that the level of albumin was decreased in Rheumatoid arthritis patients. This low concentration of albumin in Rheumatoid arthritis patients may owing to excessive albumin consumption caused by inflammatory substances.
Red blood cell distribution width is a parameter that reflects the heterogeneity of erythrocyte volume, expressed as the coefficient of variation of red blood cell volume. It is mainly used to differentiate types of anemia. However, some studies have shown that an elevated Red blood cell distribution was positively correlated with the level of inflammation.
Red blood cell distribution was increased in patients with Rheumatoid arthritis, which was associated with inflammation, suggesting that Red blood cell distribution may be a potential auxiliary marker for indicating inflammation process in Rheumatoid arthritis conveniently.
In subjects with articular pain, Red blood cell distribution interpretation is a useful tool in clinical practice to distinguish between articular inflammatory and non-inflammatory joint diseases, as with C-reactive protein. Red blood cell distribution seems to be a surrogate marker of the inflammatory process.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 40 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study will include adult RA patients consecutively presented at the Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals from both inpatient department and outpatient clinic.
Inclusion Criteria:
Exclusion Criteria:1. Individuals with concomitant other autoimmune diseases 2. RA patients with anemia, pregnancy, postpartum, diabetes, obesity hypertension.
Blood and serum samples
Procedure: Blood and serum samples
The blood and serum samples will taken from RA patients
Assessment of level of Red blood cell distribution width
Red blood cell distribution width will be measured.
Time frame: Through study completion, an average of 1 year
Assessment of level of serum Albumin in Rheumatoid arthritis patients
The level of serum Albumin will be measured in Rheumatoid arthritis patients
Time frame: Through study completion, an average of 1 year
The relation between Red blood cell distribution width and level of serum albumin in RA patients and association with the disease activity and severity.
Comparing between the Level of Red blood cell distribution width and level of serum albumin in RA patients, then comparing these results with the other routine parameters of these patients. Activity index will be done: Disease activity score (DAS28) DAS28 score of higher than 5.1 is indicative of high disease activity, DAS28 score of higher than 3.2 indicate moderate disease activity whereas DAS28 score below 3.2 indicates low disease activity. Patients are considered to be in remission if they have DAS28 score lower than 2.6 Health assessment questionnaire-disability index (HAQ-DI) will be done, It is used as a subjective measure of physical function of RA patients .There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Time frame: Through study completion, an average of 1 year
Plan to share: No — study the relation between RDW and level of serum albumin in RA patients and association with the disease activity and severity.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Assiut University