Trial Information

Summary: 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

Sponsor:

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 Design / Study Details:

  • Purpose:
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2007

Trial Registration Date: 08/22/2007

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Aniston, AL 36207
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:53:55 PM


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