A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.

Key facts

Study ID

NCT00535782

Run by

Hoffmann-La Roche

People needed

132

Starts

2007-10-31

Expected to finish

2011-01-31

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age
• rheumatoid arthritis (RA) of >6 months duration
• able to receive outpatient treatment
• on methotrexate for at least 12 weeks before entering study, at a stable dose of 7.5-25 mg/week for the last 8 weeks
• oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) permitted, if at a stable dose for 4 weeks before study start

You may not qualify if…

• major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering study
• history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA
• inadequate response to anti-tumor necrosis factor (TNF) agent during the 6 months prior to baseline, or inadequate response to >2 anti-TNF agents
• initiation of treatment with lipid lowering agents within 12 weeks prior to baseline

Where it is running

• Pinnacle Research Group; Llc, Central — Anniston, Alabama, United States
• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Advanced Arthritis Care & Research — Scottsdale, Arizona, United States
• Catalina Pointe Clinical Research, Inc. — Tucson, Arizona, United States
• Pacific Arthritis Care Center — Los Angeles, California, United States
• Arthritis & Rheumatism; Disease Specialities — Aventura, Florida, United States
• Science and Research Institute, Inc. — Jupiter, Florida, United States
• Arthritis Center Palm Harbor — Palm Harbor, Florida, United States
• Arthritis Rsrch of Florida, Inc. — Palm Harbor, Florida, United States
• Sarasota Arthritis Center; Research Dept — Sarasota, Florida, United States
• Burnette & Silverfield, MDS — Tampa, Florida, United States
• Arthritis & Rheumatology of Georgia — Atlanta, Georgia, United States
• Deerbrook Medical Associates — Vernon Hills, Illinois, United States
• Johns Hopkins Uni — Baltimore, Maryland, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Jackson Arthritis Clinic — Flowood, Mississippi, United States
• Physicians Group, LC DBA Rheumatology & Internal Medicine Associates — St Louis, Missouri, United States
• NJP Clinical Research — Clifton, New Jersey, United States
• Asheville Arthritis & Osteoporosis Center, PA — Asheville, North Carolina, United States
• Health Research of Oklahoma, Llc — Oklahoma City, Oklahoma, United States
• Lehigh Valley Hospital; Dept of Medicine — Allentown, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Clinical Research Center of Reading — Wyomissing, Pennsylvania, United States
• Houston Inst. For Clinical Research — Houston, Texas, United States
• Texas Research Center — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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