Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis

Sponsor
Maria Stoenoiu
Study ID
NCT02837146
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab (TCZ) — BIOLOGICAL
    Induction phase: TCZ subcutaneously (162 mg weekly) from baseline to week 24
  • Methotrexate (MTX) — DRUG
    Induction and maintenance phase: Methotrexate 15-20 mg/week from baseline to week 54

Study Details

This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate (MTX).

Key Dates

Start date
Dec 31, 2015
Status verified
Jul 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab (TCZ) + Methotrexate (MTX)
    Induction phase: From week 0 to week 24, all subjects will receive TCZ and MTX Maintenance phase: From week 24 to week 54, all subjects will receive MTX

Primary Outcome Measure

Change in global ultrasound scoring system (GLOSS) at MCP (2-5 joints of both hands) and wrist joints [ Time Frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54 ]

Central Contacts

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