Targeted Ultrasound in Rheumatoid Arthritis

Sponsor
University of Leeds
Study ID
NCT02056184
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.

Key Dates

Start date
Dec 31, 2013
Status verified
Oct 2019
Primary completion
Dec 31, 2017
Completion
Jul 31, 2019

Study Design

Enrollment
183 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab, masked ultrasound
    Adalimumab and blinded ultrasound.
  • Experimental: Adalimumab, unmasked ultrasound
    Adalimumab and open ultrasound.

Primary Outcome Measure

Proportion of patients in whom there is a decrease in Power Doppler (PD) at week 48 after randomisation. [ Time Frame: Week 48 ]

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