14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis

NCT ID: NCT05366608

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-03-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RA patients

188 patients with RA he 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.

Serum level of 14.0- 3.0- 3.0- η protein and IL_.6

Intervention Type: DIAGNOSTIC_TEST

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

Control

192 matched controls were enrolled. T

Serum level of 14.0- 3.0- 3.0- η protein and IL_.6

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ELISA

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• postmenopausal females, patients with other rheumatic autoimmune diseases, severe infection, diabetes mellitus, hypertension, liver or kidney disease, malignancies, endocrinal diseases, pregnant or lactating females. Patients with current intake of glucocorticoids, anticonvulsants, estrogen or anti-coagulant, alcohol users, or other factors that lead to secondary osteoporosis were also excluded from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasmin A Abdelsalam, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R.21.11.1528 - 2021/11/21

Identifier Type: -

Identifier Source: org_study_id