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

Rheumatoid Arthritis Clinical Trial

— GITR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763201
• Other study ID #: BenhaU 112018
• Status: Recruiting
• Start date: November 8, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: July 2020
• Source: Benha University
• Contact: Waleed A Hassan, MD
• Phone: 02 01095000886
• Email: waleed22101979[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria:

• infection malignancy receiving treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Necrosis
• Rheumatoid Arthritis

Intervention

Diagnostic Test:
• measurement of GITR
serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein

Locations

Country	Name	City	State
Egypt	bENHA UNIVERSITY HOSPITAL	Banha	Qalubiya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	erythrocyte sedimentation rate (ESR)	ESR measured in mm/1st hour by westergren method	4 months
Primary	C reactive protein (CRP)	CRP measured in mg/L using nephlometry	4 months
Primary	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
Primary	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
Primary	rheumatoid factor	rheumatoid factor measured in U/ml using latex agglutination test	4 months
Primary	anticyclic citrullinated antibody (Anti CCP)	Anti CCP measured in Unit/ml using ELISA	4 months