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CAMEO: Canadian Methotrexate and Etanercept Outcome Study
This study is currently recruiting participants.
Verified by Amgen, September 2009
First Received: April 3, 2008   Last Updated: September 3, 2009   History of Changes
Sponsors and Collaborators: Amgen
Wyeth
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00654368
  Purpose

An open label randomized trial of etanercept and methotrexate versus etanercept alone in the treatment of rheumatoid arthritis


Condition Intervention
Rheumatoid Arthritis
Biological: Etanercept

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Canadian Methotrexate and Etanercept Outcome Study

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • DAS28 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • radiographic disease progression, physical functioning, QOL, treatment satisfaction, productivity and safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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
Etanercept + Methotrexate
Etanercept + Methotrexate
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.
Etanercept Only
Etanercept Only
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with ACR diagnosis of RA on stable dose of methotrexate for at least 24 months ready to start etanercept per approved product monograph

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654368

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
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
Sponsors and Collaborators
Amgen
Wyeth
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

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

Keywords provided by Amgen:
Rheumatoid Arthritis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 09, 2009