Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Not Applicable

Completed

• Conditions: Patient Reported Outcomes; Rheumatoid Arthritis; Musculoskeletal Ultrasound
• Interventions: Diagnostic Test: MusculoSkeletal Ultrasound

• Registration Number: NCT03228342
• Lead Sponsor: Clínica de Artritis Temprana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Status Verified: 2019-01
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound shared	MusculoSkeletal Ultrasound	Patient will be assessed with ultrasound (GUS-7 score)
Ultrasound not shared	MusculoSkeletal Ultrasound	Patient will be assessed with ultrasound (GUS-7 score)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity	Baseline	Describe ultrasound findings at the moment of inclusion in the study.
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
Change from Baseline of the Patient Reported Outcome (SF-36)	from baseline at 12 months	Minimal Clinically Significant change in SF-36
Change from Baseline of the Patient Reported Outcome (VAS-Patient)	from baseline at 12 months	Minimal Clinically Significant change in VAS-Patient

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico