NCT03999528

Brief Summary

Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 10, 2019

Last Update Submit

June 7, 2020

Conditions

Rheumatoid ArthritisOsteoporosis

Keywords

14-3-3η Protein

Outcome Measures

Primary Outcomes (1)

  • 14-3-3η Protein and RA disease activity

    percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity

    three months

Secondary Outcomes (1)

  • 14-3-3η Protein and osteoporosis in RA patients

    three months

Study Arms (2)

study group

RA Patients

Diagnostic Test: 14-3-3η Protein assay

control group

normal control

Diagnostic Test: 14-3-3η Protein assay

Interventions

14-3-3η Protein assayDIAGNOSTIC_TEST

blood sampling for assessment of serum 14-3-3η Protein

control groupstudy group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with rheumatoid arthritis attending the Rheumatology department, at Al-Azhar faculty of medicine from May 2019 to August 2019

You may qualify if:

  • Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
  • Premenopausal females.
  • On conventional DMARD with maximum 5 mg steroids.

You may not qualify if:

  • Biological treatment.
  • Previous antiresorptive treatment, or bone anabolics.
  • High dose corticosteroid.
  • Chronic renal or kidney disease.
  • Medications affecting bone metabolism.
  • Thyroid or adrenal dysfunction,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar Faculty of medicine, Rheumatology Department

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoporosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • AHMED ABOGAMAL

    Al-Azhar Faculty of medicine- Cairo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 26, 2019

Study Start

May 1, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)