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

B

Benha University

Status

Unknown

Conditions

Rheumatoid Arthritis

Treatments

Diagnostic Test: measurement of GITR

Study type

Observational

Funder types

Other

Identifiers

NCT03763201
BenhaU 112018

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion criteria

  • infection malignancy receiving treatment

Trial design

50 participants in 2 patient groups

rheumatoid arthritis
Description:
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)
Treatment:
Diagnostic Test: measurement of GITR
control group
Description:
age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum.
Treatment:
Diagnostic Test: measurement of GITR

Trial contacts and locations

1

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Central trial contact

Eman G Behiry, MD; Waleed A Hassan, MD

Data sourced from clinicaltrials.gov

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