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This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy
Technical design:
Study design: a longitudinal observational cohort study.
This study will be carried out on two groups:
Both groups will be recruited from the in-patients and out-patients' clinic of the Rheumatology, Rehabilitation& Physical Medicine Department, Benha University Hospital.
All patients will be evaluated at baseline at 6 months follow up using:
(A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3. Disease activity using DAS28 [12]
(B) Laboratory assessment:
All patients will be subjected to the following measurements:
(D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz linear transducer
Statistical analysis The collected data will be tabulated and analyzed using suitable statistical computer version.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rheumatoid arthritis | recently diagnosed rheumatoid arthritis patients in whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum and synovial fluid (if clinically determined knee effusion) |
| |
| control group | age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measurement of GITR | Diagnostic Test | serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28 tender joints count | tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients | 4 months |
| 28 swollen joints count | swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients | 4 months |
| patient's global assessment of disease activity | patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst. | 4 months |
| disease activity score of 28 joint count (DAS28) | DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * global patient assesment | 4 months |
| erythrocyte sedimentation rate (ESR) | ESR measured in mm/1st hour by westergren method | 4 months |
| C reactive protein (CRP) | CRP measured in mg/L using nephlometry | 4 months |
| grey scale12 joint score | grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule. |
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Inclusion Criteria:
Exclusion Criteria:
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2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex matched)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed A Hassan, MD | Contact | 02 01095000886 | waleed22101979@yahoo.com | |
| Eman G Behiry, MD | Contact | 00201006216116 | FATEMAHAGGAG@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| Waleed A Hassan, MD | Benha university- Qaluibya- Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| bENHA UNIVERSITY HOSPITAL | Recruiting | Banhā | Qalyubia Governorate | 13518 | Egypt |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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serum and synovial fluid samples from RA patients
| 4 months |
| power Doppler 12 joint score | power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area. | 4 months |
| rheumatoid factor | rheumatoid factor measured in U/ml using latex agglutination test | 4 months |
| anticyclic citrullinated antibody (Anti CCP) | Anti CCP measured in Unit/ml using ELISA | 4 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |