A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors | Not Recruiting
A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Cardiovascular Disease, Rheumatoid Arthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01331837
Primary Trial ID Number
Summary
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : etanercept, Drug : tocilizumab [RoActemra/Actemra]

Study Arm Groups : 2, 1

Intervention Type
See Interventions above
Primary Outcome Measures
  • 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; 5 years
Secondary Outcome Measures
  • Time from randomization to occurrence of composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina; 5 years
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
50 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Salford Royal NHS Foundation Trust
Salford
Manchester
M6 8HD
Southampton General Hospital
Southampton
England
SO16 6YD
Pfizer Investigational Site
Birmingham
West Midlands
B29 6JD
King's College Hospital
London
England
SE5 9RS
Royal Victoria Infirmary
Newcastle upon Tyne
Tyne and Wear
NE1 4LP
Pfizer Investigational Site
London
E1 1BB
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Addenbrookes Hospital
Cambridge
CB2 0QQ
Research Site
Dudley
DY1 2HQ
Research Site
London
E11 1NR
Cannock
WS11 5XY
Westcliffe-on-sea
SS0 0RY
Wrightington
WN6 9EP
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Austria, Belgium, Bosnia and Herzegovina, Canada, Chile, 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
Scientific Title
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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
WA25204
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Oct 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

07 Apr 2011

Last Updated

17 Aug 2015