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:
Hoffmann-La Roche
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
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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: tocilizumab [RoActemra/Actemra] Drug: etanercept |
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:
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 ]
| Estimated Enrollment: | 2800 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837
Show 420 Study Locations
Contacts
| Contact: Please reference Study ID Number: WA25204 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 420 Study LocationsSponsors 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: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Cardiovascular Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013