Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03228342

Acronym

ULTRAPRO

Enrollment

Registered

2017-07-24

Start date

2017-05-03

Completion date

2019-01-28

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Patient Reported Outcomes, Musculoskeletal Ultrasound

Keywords

Rheumatoid Arthritis, Ultrasound, Impact

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.

Interventions

DIAGNOSTIC_TESTMusculoSkeletal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026