Phase 3
Completed N=132
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00535782 ↗Enrolled (actual)
132
Serious AEs
13.4%
Results posted
Nov 2012
Primary outcomePrimary: Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers — 737.79; 792.78; 768.04; 777.71 nmol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers |
737.79; 792.78; 768.04; 777.71; 23.73; 22.41 | — |
| PRIMARY Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV) |
8.97; 9.01; 8.94; 8.39; -0.03; -0.68 | — |
| SECONDARY Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers |
737.79; 792.78; 792.78; 801.78; 39.03; 32.41 | — |
| SECONDARY Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV) |
8.97; 9.01; 8.98; 8.85; 0.01; -0.20 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
59; 45; 7; 4; 3; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00535782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.