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Sponsors and Collaborators: |
Amgen Wyeth |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00654368 |
An open label randomized trial of etanercept and methotrexate versus etanercept alone in the treatment of rheumatoid arthritis
Condition | Intervention |
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Rheumatoid Arthritis |
Biological: Etanercept |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Canadian Methotrexate and Etanercept Outcome Study |
Whole blood samples
Estimated Enrollment: | 250 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Etanercept + Methotrexate
Etanercept + Methotrexate
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Biological: Etanercept
Subject with RA able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk for at least 24 weeks and this dose has been stable at least 4 weeks before the baseline visit.
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Etanercept Only
Etanercept Only
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Biological: Etanercept
Subject with RA able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk for at least 24 weeks and this dose has been stable at least 4 weeks before the baseline visit.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects with ACR diagnosis of RA on stable dose of methotrexate for at least 24 months ready to start etanercept per approved product monograph
Inclusion Criteria:
18 years of age or older at the baseline visit An ACR diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months.
Active disease of at least 3 swollen joints at the baseline visit. A DAS28 score of > 3.2 at the baseline visit Have not previously received etanercept therapy. Able to start etanercept therapy per the approved product monograph Able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk for at least 24 weeks and this dose has been stable at least 4 weeks before the baseline visit.
The subject or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedure are performed.
Exclusion Criteria:
Patients who have a positive purified protein derivative (PPD) skin test and who do not have a documented completed course of anti-tuberculosis therapy. Patients who have previously received infliximab or adalimumab. Active infections within 2 weeks of the baseline visit or during the study period.
Any history of human immunodeficiency (HIV) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis B, hepatitis C, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years. Women who are pregnant or lactating or of childbearing potential who are not using adequate contraception Receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period. Presence of any significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept, as outline in the product monograph. Subjects not available for follow-up assessment or unable to comply with study procedures.
Contact: Amgen Call Center | 866-572-6436 |
Canada | |
Research Site | Recruiting |
Quebec, Canada | |
Canada, British Columbia | |
Research Site | Recruiting |
Victoria, British Columbia, Canada | |
Research Site | Recruiting |
Vancouver, British Columbia, Canada | |
Canada, Manitoba | |
Research Site | Recruiting |
Winnipeg, Manitoba, Canada | |
Canada, New Brunswick | |
Research Site | Recruiting |
Rothesay, New Brunswick, Canada | |
Canada, Newfoundland and Labrador | |
Research Site | Recruiting |
St. John's, Newfoundland and Labrador, Canada | |
Canada, Nova Scotia | |
Research Site | Recruiting |
Sydney, Nova Scotia, Canada | |
Canada, Ontario | |
Research Site | Recruiting |
Toronto, Ontario, Canada | |
Research Site | Recruiting |
Bowmanville, Ontario, Canada | |
Research Site | Recruiting |
Brampton, Ontario, Canada | |
Research Site | Recruiting |
Ottawa, Ontario, Canada | |
Research Site | Recruiting |
Burlington, Ontario, Canada | |
Research Site | Recruiting |
St Catharines, Ontario, Canada | |
Research Site | Recruiting |
Mississauga, Ontario, Canada | |
Research Site | Recruiting |
Hamilton, Ontario, Canada | |
Research Site | Recruiting |
London, Ontario, Canada | |
Research Site | Recruiting |
Newmarket, Ontario, Canada | |
Canada, Quebec | |
Research Site | Recruiting |
Laval, Quebec, Canada | |
Research Site | Recruiting |
Montreal, Quebec, Canada | |
Research Site | Recruiting |
Saint-Eustache, Quebec, Canada | |
Canada, Saskatchewan | |
Research Site | Recruiting |
Saskatoon, Saskatchewan, Canada |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20070301 |
Study First Received: | April 3, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00654368 History of Changes |
Health Authority: | Canada: Institutional Review Board |
Rheumatoid Arthritis |
Anti-Inflammatory Agents Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Folate Rheumatic Diseases Folinic Acid TNFR-Fc fusion protein Folic Acid Antagonists Immunosuppressive Agents |
Vitamin B9 Folic Acid Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Connective Tissue Diseases Methotrexate Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents TNFR-Fc fusion protein Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Abortifacient Agents |
Connective Tissue Diseases Methotrexate Anti-Inflammatory Agents, Non-Steroidal Analgesics Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Gastrointestinal Agents Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents |