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Trial information
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis.
Status: Recruiting
Protocol number: WA19923
Company division: Pharmaceutical
Official Scientific Title: A Mechanism of Action study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis (RA).
Brief summary: 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 i.v. or placebo every 4 weeks, in combination with methotrexate 7.5-25mg weekly. In Part 2, all patients will receive open label treatment with tocilizumab plus methotrexate. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Study phase: III
Study type: Interventional; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: Change from baseline in LDL-1 particle numbers, and in Pulse Wave Velocity. Timeframe: Week 12.
Key secondary outcomes: Change from baseline in LDL-1 particle numbers, and in PWV. Timeframe: Week 24.
AEs, laboratory parameters, vital signs. Timeframe: Throughout study.
Inclusion criteria:
- adult patients, 18-75 years of age;
- rheumatoid arthritis of >6 months duration;
- able to receive outpatient treatment;
- on MTX for at least 12 weeks before entering study, at a stable dose of 7.5-25mg/week for the last 8 weeks;
- oral corticosteroids and NSAIDS permitted, if at a stable dose for 4 weeks before study start.
Exclusion criteria:
- major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering the study;
- history of, or current inflammatory disease or rheumatic autoimmune disease other than RA;
- inadequate response to an anti-TNF agent during 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Anticipated start date: September, 2007
Trial registration date: 08/22/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:Canada - Edmonton, AB
- Vancouver, BC
- Winnipeg, MB
- St. John's, NL
- Hamilton, ON
- Mississauga, ON
- Ottawa, ON
- Sainte-Foy, QC
United Kingdom - Glasgow
- Manchester
- Newcastle upon Tyne
United States - Aniston, AL
- Scottsdale, AZ
- Tucson , AZ
- Aventura, FL
- Jupiter, FL
- Palm Harbor, FL
- Sarasota , FL
- Atlanta, GA
- Vernon Hills, IL
- Baltimore, MD
- Kalamazoo, MI
- Flowood, MS
- Passaic, NJ
- Asheville, NC
- Oklahoma City, OK
- Tulsa , OK
- Allentown, PA
- Duncansville, PA
- West Reading, PA
- Ponce, PR
- Houston, TX
- Sugarland, TX
- Olympia, WA
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