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Completed

NCT Number: NCT05366608

14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis

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.

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Key information

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

Other names: ELISA

Primary outcomes

  1. primary

    Time frame: 2 years

    potential association between serum 14.0-3.0-3.0- η protein level with disease activity

Secondary outcomes

  1. secondry

    Time frame: 2 years

    association between serum 14.0-3.0-3.0- η protein level with bone mineral density (BMD)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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