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CAMEO: Canadian Methotrexate and Etanercept Outcome Study

This study is currently recruiting participants.
Verified by Amgen, October 2008

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

MedlinePlus related topics:   Rheumatoid Arthritis   

ChemIDplus related topics:   Methotrexate    Etanercept    BaseLine   

U.S. FDA Resources

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

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, Ontario
Research Site     Recruiting
      Mississauga, Ontario, Canada
Research Site     Recruiting
      Hamilton, Ontario, Canada
Research Site     Recruiting
      Newmarket, Ontario, Canada
Research Site     Recruiting
      Toronto, Ontario, Canada
Canada, Quebec
Research Site     Recruiting
      Montreal, Quebec, Canada
Research Site     Recruiting
      Saint-Eustache, Quebec, Canada

Sponsors and Collaborators
Amgen
Wyeth

Investigators
Study Director:     MD     Amgen    
  More Information


AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Amgen Inc. ( Global Development Leader )
Study ID Numbers:   20070301
First Received:   April 3, 2008
Last Updated:   October 2, 2008
ClinicalTrials.gov Identifier:   NCT00654368
Health Authority:   Canada: Institutional Review Board

Keywords provided by Amgen:
Rheumatoid Arthritis  

Study placed in the following topic categories:
Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Abortifacient Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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