Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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

Detailed Description
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Technical design: Study design: a longitudinal observational cohort study. This study will be carried out on two groups: Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010 American college of rheumatology (ACR) - European league against rheumatism (EULAR) classification criteria for RA [11]. Group (II): Twenty healthy individuals of matching age and sex as control group. 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: Erythrocyte sedimentation rate (ESR). C reactive protein (CRP). Rheumatoid factor (RF) Anti-cyclic citrullinated peptide (Anti- CCP). glucocorticoid-induced tumour necrosis factor receptor related protein (GITR) (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.

Official Title
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Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Diagnostic Test: measurement of GITR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed Exclusion Criteria: infection malignancy receiving treatment

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rheumatoid arthritis<br>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) | Diagnostic Test: measurement of GITR<br>* serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein<br>|
| control group<br>age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum. | Diagnostic Test: measurement of GITR<br>* serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, glucocorticoid-induced tumour necrosis factor receptor related protein