NCT03124225

Brief Summary

The aim of this research study is to describe the impact of rheumatologist performed ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis. Primarily, to compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

April 19, 2017

Last Update Submit

April 19, 2017

Conditions

Arthritis, RheumatoidUltrasonography

Outcome Measures

Primary Outcomes (1)

  • To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment

    12 months

Study Arms (2)

Ultrasound

Early Arthritis Patients seeing a Rheumatologist who uses US for assessment routinely in clinic

Drug: DMARD

Non-Ultrasound

Early Arthritis Patients seeing a Rheumatologist who does not uses US for assessment routinely in clinic

Drug: DMARD

Interventions

DMARDDRUG
Non-UltrasoundUltrasound

Eligibility Criteria

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

Early Arthritis patients

You may qualify if:

  • Patients aged ≥18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis

You may not qualify if:

  • For the non-ultrasound arm; patients who have been referred to another rheumatologist or radiologist for ultrasound Patients who decline or who are unable to consent to the use of their medical records for research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Antirheumatic Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 21, 2017

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

April 21, 2017

Record last verified: 2016-09