Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis

Sponsor
Massachusetts General Hospital
Study ID
NCT02659150
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • tocilizumab — DRUG
    subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU).

Study Details

The purpose of this study is to test the hypothesis that anti-IL-6 therapy is effective for reducing plaque inflammation as measured by fluorine-2-deoxy-D-glucose positron emission tomography (FDG-PET) in patients with rheumatoid arthritis (RA) who are synthetic disease-modifying antirheumatic drugs (dMARD) inadequate responders and are naive to biologic therapy.

Key Dates

Start date
May 18, 2016
Status verified
Feb 2021
Primary completion
Nov 16, 2019
Completion
Nov 16, 2019

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open-Label tocilizumab
    tocilizumab will be given to rheumatoid arthritis patients at a dose of 162 mg subcutaneously a week

Primary Outcome Measure

Change in Arterial Inflammation in the Carotids [ Time Frame: Baseline and 13-18 weeks follow-up ]

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