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NCT Number: NCT00535782

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Governors of the Uni of Alberta; Heritage Medical Research Centre, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tocilizumab

Drug

Administered by intravenous infusion, 8 mg/kg every 4 weeks.

Other names: RoActemra, Actemra

Placebo

Drug

Placebo to tocilizumab administered by intravenous infusion every 4 weeks.

methotrexate

Drug

Administered orally or parenterally, 7.5-25 mg weekly.

Primary outcomes

  1. Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers

    Time frame: Baseline and Week 12

    Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.

  2. Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)

    Time frame: Baseline and Week 12

    Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.

Secondary outcomes

  1. Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers

    Time frame: Baseline and Week 24

    Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.

  2. Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)

    Time frame: Baseline and Week 24

    Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.

  3. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to Week 24

    A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity.

    A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes.

    AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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).

Important dates

Study start
2007
Primary completion
2008
Study completion
2011
First posted
Sep 26, 2007
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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