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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  Administered by intravenous infusion, 8 mg/kg every 4 weeks.
• Placebo — DRUG
  Placebo to tocilizumab administered by intravenous infusion every 4 weeks.
• Methotrexate — DRUG
  Administered orally or parenterally, 7.5-25 mg weekly.

Study Details

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 Dates

Start date

Oct 31, 2007

Status verified

Jun 2017

Primary completion

Sep 30, 2008

Completion

Jan 31, 2011

Study Design

Enrollment

132 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TCZ + MTX
  Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks. From Week 24 to Week 104, participants received open-label TCZ 8 mg/kg every 4 weeks plus 7.5-25 mg MTX weekly.
• Placebo Comparator: Placebo + MTX
  Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks. From Week 24 to 104, participants received open-label tocilizumab (TCZ) 8 mg/kg every 4 weeks plus 7.5-25 mg MTX.

Primary Outcome Measure

Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers [ Time Frame: Baseline and Week 12 ]

Locations (26)

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