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Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes (ULTRAPRO)

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ClinicalTrials.gov Identifier: NCT03228342
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Patient Reported Outcomes Musculoskeletal Ultrasound Diagnostic Test: MusculoSkeletal Ultrasound

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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)
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

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 not be informed to his/her attending Rheumatologist.

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



Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228342


Contacts
Contact: César Sifuentes, MD 00525549974395 cesar.sifuentes86@gmail.com
Contact: Clínica AR INCMNSZ protocolosar@live.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14000
Contact: César Sifuentes, MD       cesar.sifuentes86@gmail.com   
Sponsors and Collaborators
Clínica de Artritis Temprana
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Study Director: Virginia Pascual, MD INCMNSZ
More Information

Publications:
Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S14-36. doi: 10.1002/acr.20621. Review.

Responsible Party: Clínica de Artritis Temprana
ClinicalTrials.gov Identifier: NCT03228342     History of Changes
Other Study ID Numbers: IRE-2218-17/19-1
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clínica de Artritis Temprana:
Rheumatoid Arthritis
Ultrasound
Impact

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases