A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331837
First received: April 7, 2011
Last updated: February 5, 2015
Last verified: February 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease, Rheumatoid Arthritis |
Drug: etanercept Drug: tocilizumab [RoActemra/Actemra] |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
rheumatoid arthritis
MedlinePlus related topics:
Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 3123 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks
|
| Active Comparator: 2 |
Drug: etanercept
50 mg subcutaneously weekly
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837
Show 420 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837
Show 420 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01331837 History of Changes |
| Other Study ID Numbers: | WA25204, 2010-020065-24 |
| Study First Received: | April 7, 2011 |
| Last Updated: | February 5, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Cardiovascular Diseases Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases TNFR-Fc fusion protein Analgesics Analgesics, Non-Narcotic |
Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015