A Study of Tocilizumab in Comparison to Etanercept in Participants With Rhe... | Completed
A Study of Tocilizumab in Compariso... | Completed
A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

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Medical Conditions
  • Cardiovascular Disease, Rheumatoid Arthritis
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01331837

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of tocilizumab in comparison to etanercept in participants with rheumatoid arthritis. Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 mg etanercept weekly, with or without non-biologic disease modifying anti-rheumatic drug (DMARD). 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

Study Arm Groups : Etanercept, Tocilizumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Time from randomization to occurrence of the primary major 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 cardiovascular composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina; 5 years; Percentage of Participants with Adverse Events and Serious Adverse Events; 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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:

    - Male and female participants, greater than or equal to (>/=) 50 years of age

    - Participants with moderate to severe rheumatoid arthritis of >/=6 months duration

    - Inadequate response to at least one non-biologic DMARD

    - Positive for Rheumatoid Factor (RF) and/or anti-cyclic citrullinated peptide (CCP) antibodies at screening

    - Have a C-Reactive Protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL) at screening or at the baseline visit

    - Swollen joint count (SJC) and Tender joint count (TJC) >/= 8 during screening or at the baseline visit

    - History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis

    - At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >/= 4 weeks

    - Females of childbearing potential must have a negative pregnancy test within 28 days of randomization and must be ready to use reliable contraceptive methods

    Exclusion Criteria:

    - Major surgery (including joint surgery or coronary revascularization) 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 ischemic attack, or acute coronary syndrome)

    - Current or previous (within the past 2 years) evidence of serious uncontrolled concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease

    - Uncontrolled disease states, such as asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids

    - Pre-existing central nervous system demyelinating or seizure disorders

    - History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations

    - Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion

    - Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds

    - Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit

    - Active tuberculosis (TB) requiring treatment within 3 years prior to baseline

    - Latent TB diagnosed during screening that has not been appropriately treated

    - Primary or secondary immunodeficiency (history of or currently active)

    - Moderate to severe heart failure

    - Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years

    - Breast feeding mothers

    - History of alcohol, drug or chemical abuse within the six months prior to screening

    - Participants with lack of peripheral venous access

    - Participants with a history of allergic reactions to latex

    - Previous treatment with non-TNF-inhibitor biologic therapy

    - Treatment with any investigational agent within four weeks of screening visit

    - Treatment with any cell depleting therapies within 1 year of baseline

    - Treatment with IV gamma globulin, plasmapheresis or Prosorba? column within six months of baseline visit

    - Immunization with a live/attenuated vaccine within four weeks prior to baseline visit

    - Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
E1 1BB
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Southampton General Hospital
Southampton
England
SO16 6YD
GSK Investigational Site
Cambridge
CB2 0QQ
King's College Hospital
London
SE5 9RS
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Cannock
WS11 5XY
Dudley
DY1 2HQ
London
E11 1NR
Southend-on-Sea
SS0 0RY
Appley Bridge
WN6 9EP
Pfizer Investigational Site
Birmingham
West Midlands
B29 6JD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 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

Jun 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Apr 2011

Date updated in source

01 Sep 2016