Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate

Study Identifier
P15-074
CT.gov Identifier
NCT02786563
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe RA despite treatment with methotrexate (MTX). * Eligible to use adalimumab according to the local label without any contraindication. * Naïve to adalimumab, and participants with prior exposure to any other biologic disease-modifying antirheumatic drugs (DMARDs) should have experienced at least five half-lives of the biologics after treatment discontinuation. * Participants for whom investigators decided to prescribe adalimumab as per local label and are initiating adalimumab at baseline.
    Exclusion Criteria:
    * Other inflammatory condition which may affect the signs on joints ultrasound (eg, gouty arthritis, or other chronic rheumatic disease besides RA). * Currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days of the baseline visit. * Participants with contraindication or are not appropriate to use adalimumab according to local label or investigators' judgment.

    Protocol Summary

    Prospective, post-marketing, multi-center, open-label study to explore if the initiation of adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score using 36-joint plus 4-tendon scoring system, and validate the applicability of different simplified US joint scoring systems.

    Study Locations

    Location
    Status
    Location
    Peking University Peoples Hospit /ID# 148961
    Beijing, Beijing Municipality, China, 100044
    Status
    Not applicable
    Location
    Xijing Hospital /ID# 148960
    Xi'an, Shaanxi, China, 710032
    Status
    Not applicable
    Location
    Hosp Ppl Liberation Army 301 /ID# 148962
    Beijing, China, 100034
    Status
    Not applicable
    Location
    Renji Hosp, Shanghai Jiaotong /ID# 148959
    Shanghai, China, 200127
    Status
    Not applicable