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

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Diagnostic test: measurement of GITR

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Egypt
  • Qalubiya
    • Banhā, Qalubiya, Egypt, 13518
      • Recruiting
      • Benha University Hospital
      • Contact: Ali Fouda, MD; Phone Number: 00201066640220; Email: ali71960@hotmail.com
      • Contact: Waleed A Hassan, MD; Phone Number: 00201095000886; Email: waleed22101979@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex matched)

Description

Inclusion Criteria:

• fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria:

• infection malignancy receiving treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Diagnostic test: measurement of GITR; serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein
control group; 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; serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Waleed A Hassan, MD, Benha university- Qaluibya- Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2018
• Primary Completion (ANTICIPATED): September 15, 2020
• Study Completion (ANTICIPATED): September 15, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; glucocorticoid-induced tumour necrosis factor receptor related protein
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Necrosis
• Other Study ID Numbers: BenhaU 112018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No