Rheumatoid Arthritis Hematological Indices

• Conditions: Rheumatoid Arthritis; Serum Albumin Low
• Interventions: Procedure: Blood and serum samples

• Registration Number: NCT04416997
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-05-15
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2022-10-29
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult RA Patients who fulfilled the 2010 European league against rheumatism criteria for the classification of RA

Exclusion Criteria

1. Individuals with concomitant other autoimmune diseases 2. RA patients with anemia, pregnancy, postpartum, diabetes, obesity hypertension.

2. Patients with age less than 18 years 4. Patients with end stage organ failure.

3. Patients with liver diseases.

4. Patients with hematological disorders.

5. Patients with malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis patients	Blood and serum samples	Blood and serum samples

Primary Outcome Measures

Name	Time	Method
Assessment of level of Red blood cell distribution width	Through study completion, an average of 1 year	Red blood cell distribution width will be measured.
Assessment of level of serum Albumin in Rheumatoid arthritis patients	Through study completion, an average of 1 year	The level of serum Albumin will be measured in Rheumatoid arthritis patients

Secondary Outcome Measures

Name	Time	Method
The relation between Red blood cell distribution width and level of serum albumin in RA patients and association with the disease activity and severity.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Assiut, Egypt