NCT03274570

Brief Summary

The aims of the research are:

  • To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
  • To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Status
unknown

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

August 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 7, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 27, 2017

Last Update Submit

September 5, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • quality of life

    Health assessment questionnaire disability index (HAQ)

    one year

Secondary Outcomes (1)

  • hand function

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals during the period from September 2017 until September 2018

You may qualify if:

  • Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.

You may not qualify if:

  • Patients with other rheumatic diseases.
  • Patients less than 18 years old.
  • Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
  • Patient with any recent history of hand trauma, or surgery.
  • Patient with neurological involvement as , peripheral neuropathy and radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC;ESR,liver function test and kidney function test

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Safaa A Mahran, professor

    Assiut University

    STUDY DIRECTOR

  • Essam Abda, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Essraa abd el razek, doctor

CONTACT

01009558495essraamohammed2016@yahoo.com

Manal Hassanien, lecturer

CONTACT

01062679200manal_hassanien@yahoo.com

Study Design

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

Study Record Dates

First Submitted

August 27, 2017

First Posted

September 7, 2017

Study Start

October 1, 2017

Primary Completion

October 30, 2018

Study Completion

January 31, 2019

Last Updated

September 7, 2017

Record last verified: 2017-08