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Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes (ULTRAPRO)

Primary Purpose

Rheumatoid Arthritis, Patient Reported Outcomes, Musculoskeletal Ultrasound

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

MusculoSkeletal Ultrasound

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Ultrasound, Impact

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ultrasound shared

Ultrasound not shared

Arm Description

Patient will be assessed with ultrasound (GUS-7 score)

Outcomes

Primary Outcome Measures

Change from Baseline of the Patient Reported Outcome (HAQ)

Minimal Clinically Significant change in HAQ

Change from Baseline of the Patient Reported Outcome (RADAI)

Minimal Clinically Significant change in RADAI

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

Minimal Clinically Significant change in SF-36

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

Minimal Clinically Significant change in VAS-Patient

Secondary Outcome Measures

Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity

Describe ultrasound findings at the moment of inclusion in the study.

Clinical relapse: Proportion of patients with relapse after the intervention in both groups

Describe the proportion of patients with relapse after the intervention in both groups.

Change from Baseline of the Patient Reported Outcome (HAQ)

Minimal Clinically Significant change in HAQ

Change from Baseline of the Patient Reported Outcome (RADAI)

Minimal Clinically Significant change in RADAI

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

Minimal Clinically Significant change in SF-36

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

Minimal Clinically Significant change in VAS-Patient

Full Information

NCT ID

NCT03228342

First Posted

May 3, 2017

Last Updated

January 29, 2019

Sponsor

Clínica de Artritis Temprana

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1. Study Identification

Unique Protocol Identification Number

NCT03228342

Brief Title

Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Acronym

ULTRAPRO

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

May 3, 2017 (Actual)

Primary Completion Date

January 28, 2019 (Actual)

Study Completion Date

January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clínica de Artritis Temprana

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Patient Reported Outcomes, Musculoskeletal Ultrasound

Keywords

Rheumatoid Arthritis, Ultrasound, Impact

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound shared

Arm Type

Experimental

Arm Description

Patient will be assessed with ultrasound (GUS-7 score)

Arm Title

Ultrasound not shared

Arm Type

Experimental

Arm Description

Patient will be assessed with ultrasound (GUS-7 score)

Intervention Type

Diagnostic Test

Intervention Name(s)

MusculoSkeletal Ultrasound

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

MusculoSkeletal Ultrasound

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline of the Patient Reported Outcome (HAQ)

Description

Minimal Clinically Significant change in HAQ

Time Frame

From baseline at 6 months

Title

Change from Baseline of the Patient Reported Outcome (RADAI)

Description

Minimal Clinically Significant change in RADAI

Time Frame

from baseline at 6 months

Title

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

Description

Minimal Clinically Significant change in SF-36

Time Frame

from baseline at 6 months

Title

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

Description

Minimal Clinically Significant change in VAS-Patient

Time Frame

from baseline at 6 months

Secondary Outcome Measure Information:

Title

Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity

Description

Describe ultrasound findings at the moment of inclusion in the study.

Time Frame

Baseline

Title

Clinical relapse: Proportion of patients with relapse after the intervention in both groups

Description

Describe the proportion of patients with relapse after the intervention in both groups.

Time Frame

baseline and 6 months

Title

Change from Baseline of the Patient Reported Outcome (HAQ)

Description

Minimal Clinically Significant change in HAQ

Time Frame

from baseline at 12 months

Title

Change from Baseline of the Patient Reported Outcome (RADAI)

Description

Minimal Clinically Significant change in RADAI

Time Frame

from baseline at 12 months

Title

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

Description

Minimal Clinically Significant change in SF-36

Time Frame

from baseline at 12 months

Title

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

Description

Minimal Clinically Significant change in VAS-Patient

Time Frame

from baseline at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virginia Pascual, MD

Organizational Affiliation

INCMNSZ

Official's Role

Study Director

Facility Information:

Facility Name

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

12. IPD Sharing Statement

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Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

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