14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis

NCT05366608 | Completed DMC

• 1 other identifier: R.21.11.1528 - 2021/11/21
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease Activity

Keywords

Rheumatoid arthritis; osteoporosis; 14.0- 3.0- 3.0- η

Outcome Measures

Primary Outcomes (1)

• primary

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

  2 years

Secondary Outcomes (1)

• secondry

  2 years

Study Arms (2)

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.

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

Control

192 matched controls were enrolled. T

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

Interventions

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.

Also known as: ELISA

Control; RA patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoporosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yasmin A Abdelsalam, MD

  Mansoura University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: January 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 10, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

EG (1)