Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Clínica de Artritis Temprana94 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis Patient Reported Outcomes Musculoskeletal Ultrasound

Interventions

MusculoSkeletal UltrasoundDIAGNOSTIC_TEST

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.

MusculoSkeletal UltrasoundDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

Outcomes

Primary Outcomes

Change from Baseline of the Patient Reported Outcome (HAQ)

Minimal Clinically Significant change in HAQ

Time frame: From baseline at 6 months

Change from Baseline of the Patient Reported Outcome (RADAI)

Minimal Clinically Significant change in RADAI

Time frame: from baseline at 6 months

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

Minimal Clinically Significant change in SF-36

Time frame: from baseline at 6 months

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

Minimal Clinically Significant change in VAS-Patient

Time frame: from baseline at 6 months

Secondary Outcomes

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

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

Time frame: Baseline

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.

Time frame: baseline and 6 months

Change from Baseline of the Patient Reported Outcome (HAQ)

Minimal Clinically Significant change in HAQ

Time frame: from baseline at 12 months

Change from Baseline of the Patient Reported Outcome (RADAI)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.