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

NCT ID: NCT03763201

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-08

Study Completion Date

2020-09-15

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

measurement of GITR

Intervention Type DIAGNOSTIC_TEST

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.

measurement of GITR

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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measurement of GITR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria

* infection malignancy receiving treatment
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Ahmed Salaheldeen Hassan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed A Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Benha university- Qaluibya- Egypt

Locations

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bENHA UNIVERSITY HOSPITAL

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waleed A Hassan, MD

Role: CONTACT

02 01095000886

Eman G Behiry, MD

Role: CONTACT

00201006216116

Facility Contacts

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Ali Fouda, MD

Role: primary

00201066640220

Waleed A Hassan, MD

Role: backup

00201095000886

Other Identifiers

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BenhaU 112018

Identifier Type: -

Identifier Source: org_study_id

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