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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05366608
Enrollment
188
Registered
2022-05-09
Start date
2019-01-01
Completion date
2022-03-10
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease Activity

Keywords

Rheumatoid arthritis, osteoporosis, 14.0- 3.0- 3.0- η

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,

Interventions

DIAGNOSTIC_TESTSerum 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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
primary2 yearspotential association between serum 14.0-3.0-3.0- η protein level with disease activity

Secondary

MeasureTime frameDescription
secondry2 yearsassociation between serum 14.0-3.0-3.0- η protein level with bone mineral density (BMD)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026