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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03763201
Acronym
GITR
Enrollment
50
Registered
2018-12-04
Start date
2018-11-08
Completion date
2020-09-15
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTmeasurement of GITR

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

Sponsors

Benha University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion criteria

* infection malignancy receiving treatment

Design outcomes

Primary

MeasureTime frameDescription
28 tender joints count4 monthstender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
28 swollen joints count4 monthsswollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
patient's global assessment of disease activity4 monthspatient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
disease activity score of 28 joint count (DAS28)4 monthsDAS28 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
erythrocyte sedimentation rate (ESR)4 monthsESR measured in mm/1st hour by westergren method
C reactive protein (CRP)4 monthsCRP measured in mg/L using nephlometry
grey scale12 joint score4 monthsgrey 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 score4 monthspower 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.
rheumatoid factor4 monthsrheumatoid factor measured in U/ml using latex agglutination test
anticyclic citrullinated antibody (Anti CCP)4 monthsAnti CCP measured in Unit/ml using ELISA

Countries

Egypt

Contacts

Primary ContactWaleed A Hassan, MD
waleed22101979@yahoo.com02 01095000886
Backup ContactEman G Behiry, MD
FATEMAHAGGAG@GMAIL.COM00201006216116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026