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

• Conditions: Rheumatoid Arthritis
• Interventions: Diagnostic Test: measurement of GITR

• Registration Number: NCT03763201
• Lead Sponsor: Benha University

Brief Summary

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

1. 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:

1. Erythrocyte sedimentation rate (ESR).

2. C reactive protein (CRP).

3. Rheumatoid factor (RF)

4. Anti-cyclic citrullinated peptide (Anti- CCP).

5. 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

2. Statistical analysis The collected data will be tabulated and analyzed using suitable statistical computer version.

Study Timeline

• Study Start: 2018-11-08
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria

• infection malignancy receiving treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rheumatoid arthritis	measurement of GITR	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	measurement of GITR	age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum.

Primary Outcome Measures

Name	Time	Method
rheumatoid factor	4 months	rheumatoid factor measured in U/ml using latex agglutination test
28 swollen joints count	4 months	swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
disease activity score of 28 joint count (DAS28)	4 months	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
grey scale12 joint score	4 months	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.
power Doppler 12 joint score	4 months	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.
anticyclic citrullinated antibody (Anti CCP)	4 months	Anti CCP measured in Unit/ml using ELISA
28 tender joints count	4 months	tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
patient's global assessment of disease activity	4 months	patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
erythrocyte sedimentation rate (ESR)	4 months	ESR measured in mm/1st hour by westergren method
C reactive protein (CRP)	4 months	CRP measured in mg/L using nephlometry

Trial Locations

Locations (1)

bENHA UNIVERSITY HOSPITAL; 🇪🇬 Banhā, Qalubiya, Egypt