Clinical trial NCT03763201: Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in Rheumatoid Arthritis
Official title: Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
glucocorticoid-induced tumour necrosis factor receptor related protein
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex matched)

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.

Eligibility criteria: Inclusion Criteria:

* fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria:

* infection malignancy receiving treatment

Primary outcomes:
measure: 28 tender joints count
timeFrame: 4 months
measure: 28 swollen joints count
timeFrame: 4 months
measure: patient's global assessment of disease activity
timeFrame: 4 months
measure: disease activity score of 28 joint count (DAS28)
timeFrame: 4 months
measure: erythrocyte sedimentation rate (ESR)
timeFrame: 4 months
measure: C reactive protein (CRP)
timeFrame: 4 months
measure: grey scale12 joint score
timeFrame: 4 months
measure: power Doppler 12 joint score
timeFrame: 4 months
measure: rheumatoid factor
timeFrame: 4 months
measure: anticyclic citrullinated antibody (Anti CCP)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: bENHA UNIVERSITY HOSPITAL
state: Qalubiya
Study officials:
affiliation: Benha university- Qaluibya- Egypt
name: Waleed A Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: