Skip to main content
OpenTrials
Completed

NCT Number: NCT03228342

Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Musculoskeletal Ultrasound Patient Reported Outcomes Rheumatic Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Musculoskeletal ultrasound

Diagnostic 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.

Primary outcomes

  1. Change from Baseline of the Patient Reported Outcome (HAQ)

    Time frame: From baseline at 6 months

    Minimal Clinically Significant change in HAQ

  2. Change from Baseline of the Patient Reported Outcome (RADAI)

    Time frame: from baseline at 6 months

    Minimal Clinically Significant change in RADAI

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

    Time frame: from baseline at 6 months

    Minimal Clinically Significant change in SF-36

  4. 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

  1. 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.

  2. 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.

  3. Change from Baseline of the Patient Reported Outcome (HAQ)

    Time frame: from baseline at 12 months

    Minimal Clinically Significant change in HAQ

  4. Change from Baseline of the Patient Reported Outcome (RADAI)

    Time frame: from baseline at 12 months

    Minimal Clinically Significant change in RADAI

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

    Time frame: from baseline at 12 months

    Minimal Clinically Significant change in SF-36

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

    Time frame: from baseline at 12 months

    Minimal Clinically Significant change in VAS-Patient

Sponsors and collaborators

Lead sponsor

Clínica de Artritis Temprana

Other

Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Registry information

Official study 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)

Acronym: ULTRAPRO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.