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NCT00535782 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
132
Enrollment target

NCT00535782: Completed Phase 3 study, sponsored by Hoffmann-La Roche.

NCT00535782 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00535782, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
132 participants
Enrollment target

Study 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 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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Tocilizumab
  • DRUG Methotrexate

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2007-10-31
Est. Completion 2011-01-31
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT00535782 record still lists

NCT00535782 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00535782 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00535782 about?

NCT00535782 is a clinical study titled "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 place...

What is the current status of trial NCT00535782?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2007-10-31. Estimated completion is 2011-01-31.

What interventions are being tested in trial NCT00535782?

The interventions under investigation include: Placebo (DRUG), Tocilizumab (DRUG), Methotrexate (DRUG).

Who is sponsoring clinical trial NCT00535782?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00535782's enrollment target sits among peer trials

132 1588th of 2000 higher than 408 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00535782, the US trial registry maintained by the National Library of Medicine. NCT00535782 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.