The Impact of Musculoskeletal Ultrasound-added to Clinical Evaluations- on Patient Reported Outcomes: A Prospective Study of Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity (ULTRAPRO)

Clínica de Artritis Temprana1 site in 1 country94 target enrollmentMay 3, 2017

ConditionsRheumatoid Arthritis Patient Reported Outcomes Musculoskeletal Ultrasound

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Clínica de Artritis Temprana
Enrollment: 94
Locations: 1
Primary Endpoint: Change from Baseline of the Patient Reported Outcome (HAQ)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient Reported Outcomes.

Registry

clinicaltrials.gov

Start Date

May 3, 2017

End Date

January 28, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Clínica de Artritis Temprana

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A clinical diagnosis of RA made at the discretion of the attending experienced rheumatologist.
•Patients classified in remission/low disease activity

Exclusion Criteria

•\<16 years old.
•Patient with recent trauma in the evaluated joints.
•Luxation in the MCP, PIP or MTP joints.

Outcomes

Primary Outcomes

Change from Baseline of the Patient Reported Outcome (HAQ)

Time Frame: From baseline at 6 months

Minimal Clinically Significant change in HAQ

Change from Baseline of the Patient Reported Outcome (RADAI)

Time Frame: from baseline at 6 months

Minimal Clinically Significant change in RADAI

Change from Baseline of the Patient Reported Outcome (SF-36)

Time Frame: from baseline at 6 months

Minimal Clinically Significant change in SF-36

Change from Baseline of the Patient Reported Outcome (VAS-Patient)

Time Frame: from baseline at 6 months

Minimal Clinically Significant change in VAS-Patient

Secondary Outcomes

Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity(Baseline)
Clinical relapse: Proportion of patients with relapse after the intervention in both groups(baseline and 6 months)
Change from Baseline of the Patient Reported Outcome (HAQ)(from baseline at 12 months)
Change from Baseline of the Patient Reported Outcome (RADAI)(from baseline at 12 months)
Change from Baseline of the Patient Reported Outcome (SF-36)(from baseline at 12 months)
Change from Baseline of the Patient Reported Outcome (VAS-Patient)(from baseline at 12 months)