A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).

F. Hoffmann-La Roche Limited0 sites120 target enrollmentFebruary 13, 2008

Overview

No summary available.

Registry

who.int

Start Date

February 13, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

F. Hoffmann-La Roche Limited

•1\. Able and willing to give written informed consent and comply with the
•requirements of the study protocol
•2\. Patients with rheumatoid arthritis \>6 months duration diagnosed according to the
•revised 1987 American College of Rheumatology criteria.
•3\. Able to receive treatment on an outpatient basis
•4\. Have received MTX for at least 12 weeks immediately prior to baseline, of which
•the last 8 weeks prior to baseline must have been at a stable dose of between 7\.5
•and 25 mg/week (oral or parenteral). Patients who have partially responded MTX,
•but discontinued treatment for surgery or pregnancy may reinitiate treatment at least
•8 weeks prior to baseline with a stable dose for at least 4 weeks.

•1\. Major surgery (including joint surgery) within eight weeks prior to screening or
•surgery planned to occur during the first 24 weeks of the study
•2\. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma,
•polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
•pulmonary fibrosis or Felty’s syndrome). Sjögren’s Syndrome with RA is allowable
•3\. Functional class IV as defined by the ACR Classification of Functional Status in
•4\. Prior history of or current inflammatory joint disease other than RA (e.g., gout,
•reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme
•5\. Patients weighing \>150 kg
•6\. Patients with uncontrolled co\-morbidities, such as diabetes (insulin\-dependent),