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

NCT03763201 | Unknown DMC

• 1 other identifier: BenhaU 112018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; glucocorticoid-induced tumour necrosis factor receptor related protein

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

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

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

Interventions

measurement of GITR DIAGNOSTIC_TEST

serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein

control group; rheumatoid arthritis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

You may not qualify if:

• infection malignancy receiving treatment

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

bENHA UNIVERSITY HOSPITAL

Banhā, Qalyubia Governorate, 13518, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and synovial fluid samples from RA patients

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Waleed A Hassan, MD

  Benha university- Qaluibya- Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed A Hassan, MD

CONTACT

02 01095000886; waleed22101979@yahoo.com

Eman G Behiry, MD

CONTACT

00201006216116; FATEMAHAGGAG@GMAIL.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 4, 2018
• Study Start: November 8, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

EG (1)