NCT05366608

14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis

14.0- 3.0- 3.0- η Protein is Associated With Disease Activity and Osteoporosis in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 188 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Aim of work: to explore the potential association between serum 14.0-3.0-3.0- η protein level with disease activity and bone mineral density (BMD) in Egyptian patients with rheumatoid arthritis (RA). 188 patients with RA and 192 matched controls were enrolled. The RA activity parameters were evaluated in RA patients. BMD was measured. Serum level of 14.0- 3.0- 3.0- η protein and IL\_.6 were estimated for all participants by ELISA.

Detailed description

A total of 200 RA patients were invited to be enrolled in this study. Patients were diagnosed as having RA by the 2010 European-league-against-Rheumatism- (EULAR) and American-College-of-rheumatology (ACR) classification criteria for RA. Patients were collected from the outpatient clinic of the Rheumatology and Rehabilitation Department, Mansoura University Hospital. All participants underwent detailed medical history taking as well as clinical examination. The medical records of all patients were carefully reviewed. Data collection included age, gender, past medical history, current and past drug intake. In RA patients, the disease duration, duration of the morning stiffness, tender joint count (TJC) and swollen joint count (SJC) were reported. The activity of RA was measured by disease activity score 28 (DAS.28) based on the erythrocyte sedimentation rate (ESR) level (DAS28-ESR) \[19\]. The intensity of perceived pain was assessed by the visual analog scale (VAS) 100-mm scale. Bone mineral density (BMD) was measured using dual energy X-ray absorptiometry (DEXA) at proximal femur for all participants who were categorized into normal, osteopenic, or osteoporotic according to the definition of the World Health Organization (WHO) of the recorded T score A commercially available human IL\_.6 ELISA kit (GenProbe, Diaclone, France) was used to measure IL\_.6 serum level following the instructions of the manufacturer. Serum level of 14.0- 3.0- 3.0- η protein was determined by ELISA for all participants,

Conditions

• Disease Activity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum level of 14.0- 3.0- 3.0- η protein and IL_.6	Serum level of 14.0- 3.0- 3.0- η protein and IL\_.6 were estimated for all participants by ELISA.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-03-01
• Completion: 2022-03-10
• First posted: 2022-05-09
• Last updated: 2022-05-09

Locations

1 site across 1 country: Egypt