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ULTRAPRO: Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Sponsor
Clínica de Artritis Temprana (Other)
Overall Status
Completed
CT.gov ID
NCT03228342
Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
94
Enrollment
1
Location
2
Arms
20.9
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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 Phase
  • Diagnostic Test: MusculoSkeletal Ultrasound
  • Diagnostic Test: MusculoSkeletal Ultrasound
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
94 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
Actual Primary Completion Date :
Jan 28, 2019
Actual Study Completion Date :
Jan 28, 2019

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) [From baseline at 6 months]

    Minimal Clinically Significant change in HAQ

  2. Change from Baseline of the Patient Reported Outcome (RADAI) [from baseline at 6 months]

    Minimal Clinically Significant change in RADAI

  3. Change from Baseline of the Patient Reported Outcome (SF-36) [from baseline at 6 months]

    Minimal Clinically Significant change in SF-36

  4. Change from Baseline of the Patient Reported Outcome (VAS-Patient) [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 [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 [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) [from baseline at 12 months]

    Minimal Clinically Significant change in HAQ

  4. Change from Baseline of the Patient Reported Outcome (RADAI) [from baseline at 12 months]

    Minimal Clinically Significant change in RADAI

  5. Change from Baseline of the Patient Reported Outcome (SF-36) [from baseline at 12 months]

    Minimal Clinically Significant change in SF-36

  6. Change from Baseline of the Patient Reported Outcome (VAS-Patient) [from baseline at 12 months]

    Minimal Clinically Significant change in VAS-Patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico 14000

Sponsors and Collaborators

  • Clínica de Artritis Temprana
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Study Director: Virginia Pascual, MD, INCMNSZ

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Clínica de Artritis Temprana
ClinicalTrials.gov Identifier:
NCT03228342
Other Study ID Numbers:
  • IRE-2218-17/19-1
First Posted:
Jul 24, 2017
Last Update Posted:
Jan 30, 2019
Last Verified:
Jan 1, 2019
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

Study Results

No Results Posted as of Jan 30, 2019