NCT07069088

Brief Summary

This study aims to characterize and compare patients of adult-onset RA with patients of elderly-onset RA based on the clinical manifestations, disease activity, severity parameters, and therapeutic features.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 16, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 30, 2025

Last Update Submit

July 5, 2025

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

  • Disease activity assessment

    Disease activity assessment using DAS 28 Quality of life: HAQ (health assessment questionnaire

    from enrollment time to the end of examination and investigation at 4 weeks

Study Arms (3)

Adult- onset RA group I (16-40 years)

16-40 years

Adult- onset RA group II (41-60 years)

41-60 years

EORA >60 years

\>60 years

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rheumatoid Arthritis patients

You may qualify if:

  • \) Patients fulfill the 2010 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis \[7\] 2) Age of disease onset above 16 years old. 3) patient is cooperative and can answer questions. 4) Patients who are able and willing to give written informed consent.

You may not qualify if:

  • \) Other rheumatologic or collagen diseases. 2) Age below 16 years. 3) Active infection 4) Pregnancy 5) Malignancy 6) Uncooperative patients. 7) Patient not able and willing to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology and Rehabilitation department at Sohag University Hospital

Sohag, Egypt

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples to do lab investigations

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 16, 2025

Study Start

July 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

All patients will be subjected to the following: 1. Full medical history from the patients, including Demographic data (Age, Sex, Marital status, Occupation, Residence), duration of disease, Comorbidities, and the treatments that patients receive. 2. Full clinical examination and assessment including: 1. General examination and Complete rheumatological examination. 2. Application of American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis, on all RA patients. 3. Laboratory investigations: (Blood sample will be collected into 5ml tubes containing Ethylenediaminetetraacetic acid (EDTA) ). * complete blood count (CBC) (done on fully automatic BC 21S hematology analyzer). * erythrocyte sedimentation rate (ESR). * C- reactive protein (CRP) (using Enzyme-linked immunosorbent assay (ELISA)). * rheumatoid factor (RF) (using ELISA). * anti-cyclic citrullinated peptide antibody (ACCP Ab) (using ELISA). 4. Disease activity assessm

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 3 months and ending 3 years after the publication of results")
Access Criteria
on clinical trials website

Locations

EG(1)