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A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331837
First received: April 7, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes

April 7, 2011
May 13, 2013
August 2011
April 2017   (final data collection date for primary outcome measure)
Time from randomization to occurrence of the primary major adverse adverse cardiac events, defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke of all classifications [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01331837 on ClinicalTrials.gov Archive Site
Time from randomization to occurrence of composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
  • Non-fatal myocardial infarction [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
  • Non-fatal stroke of all classifications [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Ischemic Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of RoActemra/Actemra (tocilizumab) in comparison to etanercept in patients with rheumatoid arthritis. Patients will be randomized to receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks or 50 mg etanercept subcutaneously weekly. The anticipated time on study drug is up to 5 years.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiovascular Disease, Rheumatoid Arthritis
  • Drug: tocilizumab [RoActemra/Actemra]
    8 mg/kg intravenously every 4 weeks
  • Drug: etanercept
    50 mg subcutaneously weekly
  • Experimental: 1
    Intervention: Drug: tocilizumab [RoActemra/Actemra]
  • Active Comparator: 2
    Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2800
April 2017
April 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=50 years of age
  • Patients with moderate to severe rheumatoid arthritis >/=6 months duration
  • Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD)
  • History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis

Exclusion Criteria:

  • Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • History of, or current, inflammatory joint disease other than rheumatoid arthritis
  • Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome)
  • History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
  • Active current infection or history of recurrent bacterial infection
  • Previous treatment with tocilizumab or etanercept
Both
50 Years and older
No
Contact: Please reference Study ID Number: WA25204 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Argentina,   Austria,   Belgium,   Bosnia and Herzegovina,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Ecuador,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Turkey,   United Kingdom
 
NCT01331837
WA25204, 2010-020065-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP