Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes (ULTRAPRO)

January 29, 2019 updated by: Clínica de Artritis Temprana

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound shared
Patient will be assessed with ultrasound (GUS-7 score)
Diagnostic test: MusculoSkeletal Ultrasound

Patient will be assess with ultrasound (GUS-7 score) and the results will be informed to his/her attending Rheumatologist.

The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.

Diagnostic test: MusculoSkeletal Ultrasound

Patient will be assess with ultrasound (GUS-7 score) and the results will not be informed to his/her attending Rheumatologist.

The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.
Experimental: Ultrasound not shared
Patient will be assessed with ultrasound (GUS-7 score)
Diagnostic test: MusculoSkeletal Ultrasound

Patient will be assess with ultrasound (GUS-7 score) and the results will be informed to his/her attending Rheumatologist.

The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.

Diagnostic test: MusculoSkeletal Ultrasound

Patient will be assess with ultrasound (GUS-7 score) and the results will not be informed to his/her attending Rheumatologist.

The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of the Patient Reported Outcome (HAQ)
Time Frame: From baseline at 6 months
Minimal Clinically Significant change in HAQ
From baseline at 6 months
Change from Baseline of the Patient Reported Outcome (RADAI)
Time Frame: from baseline at 6 months
Minimal Clinically Significant change in RADAI
from baseline at 6 months
Change from Baseline of the Patient Reported Outcome (SF-36)
Time Frame: from baseline at 6 months
Minimal Clinically Significant change in SF-36
from baseline at 6 months
Change from Baseline of the Patient Reported Outcome (VAS-Patient)
Time Frame: from baseline at 6 months
Minimal Clinically Significant change in VAS-Patient
from baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity
Time Frame: Baseline
Describe ultrasound findings at the moment of inclusion in the study.
Baseline
Clinical relapse: Proportion of patients with relapse after the intervention in both groups
Time Frame: baseline and 6 months
Describe the proportion of patients with relapse after the intervention in both groups.
baseline and 6 months
Change from Baseline of the Patient Reported Outcome (HAQ)
Time Frame: from baseline at 12 months
Minimal Clinically Significant change in HAQ
from baseline at 12 months
Change from Baseline of the Patient Reported Outcome (RADAI)
Time Frame: from baseline at 12 months
Minimal Clinically Significant change in RADAI
from baseline at 12 months
Change from Baseline of the Patient Reported Outcome (SF-36)
Time Frame: from baseline at 12 months
Minimal Clinically Significant change in SF-36
from baseline at 12 months
Change from Baseline of the Patient Reported Outcome (VAS-Patient)
Time Frame: from baseline at 12 months
Minimal Clinically Significant change in VAS-Patient
from baseline at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica de Artritis Temprana

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Study Director: Virginia Pascual, MD, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRE-2218-17/19-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on MusculoSkeletal Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe