Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis
NCT02837146 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2016-07-29
Summary
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).
Conditions
Interventions
- BIOLOGICAL
-
Tocilizumab (TCZ)
Induction phase: TCZ subcutaneously (162 mg weekly) from baseline to week 24
- DRUG
-
Methotrexate (MTX)
Induction and maintenance phase: Methotrexate 15-20 mg/week from baseline to week 54
Sponsors & Collaborators
-
Maria Stoenoiu
lead OTHER
Principal Investigators
-
Maria S Stoenoiu, MD, PhD · Université Catholique de Louvain
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2018-12-31
- Completion
- 2019-12-31
Countries
- Belgium
Study Locations
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