Clinical trial NCT05366608: 14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis
Official title: 14.0- 3.0- 3.0- η Protein is Associated With Disease Activity and Osteoporosis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease Activity
Keywords: Rheumatoid arthritis
osteoporosis
14.0- 3.0- 3.0- η
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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,

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

Primary outcomes:
measure: primary
timeFrame: 2 years
Secondary outcomes:
measure: secondry
timeFrame: 2 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Mansoura University Hospital
name: Yasmin A Abdelsalam, MD
role: STUDY_CHAIR
References: