CAMEO: Canadian Methotrexate and Etanercept Outcome Study

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00654368
First received: April 3, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period


Condition Intervention
Rheumatoid Arthritis
Biological: Etanercept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Disease Activity Severity 28 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The change in DAS28 from 6 month randomization to 12 months


Secondary Outcome Measures:
  • Radiographic disease progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Radiographic disease progression at 12 and 24 months as measured by joint erosion score, joint space narrowing score and total sharp score

  • Physical functioning [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Work Productivity and Activity Impairment Questionnaire (WPAI) at 6, 12, 18 and 24 months

  • Quality Of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    HAQ at 6, 12, 18 and 24 months SF-36 at 6, 12, 18 and 24 months

  • Treatment satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Treatment Satisfaction Questionnaire for medication (TSQM) at 6, 12, 18 and 24 months

  • Productivity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Work Productivity and Activity Impairment Questionnaire (WPAI) at 6, 12, 18 and 24 months

  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Serious adverse events, including serious infections, non-melanoma skin cancer and all malignancies

    All other non-serious adverse events


  • Disease Activity Severity 28 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    DAS28 remission (<.2.6), low (<3.2) and high (≥3.2) disease activity score at 6, 12, 18 and 24 months

  • Disease Activity Severity 28 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    DAS28 improvement from baseline to 6, 18 and 24 months

  • Drug Persistence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Drug persistence at 6, 12, 18 and 24 months


Biospecimen Retention:   Samples With DNA

Whole blood samples


Enrollment: 257
Study Start Date: June 2008
Study Completion Date: February 2013
Primary Completion Date: December 2012 (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 12 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 12 weeks and this dose has been stable at least 4 weeks before the baseline visit.

Detailed Description:

The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period.

  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 12 weeks 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 (see Appendix B)
  • Active disease of at least 3 swollen joints from the Disease Activity Severity 28 at the baseline visit
  • A Disease Activity Severity 28 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 (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 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 procedures are performed

Exclusion Criteria:

  • Patients who have a positive purified protein derivative (PPD) skin test and who do not have a documented course of anti-tuberculosis therapy. Patients with a positive PPD skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. The full course of anti-tuberculosis therapy must be completed
  • 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 outlined 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

Locations
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 3Y1
Research Site
Victoria, British Columbia, Canada, V8V 3P9
Research Site
Victoria, British Columbia, Canada, V8P 5P6
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, New Brunswick
Research Site
Quispamsis, New Brunswick, Canada, E2E 4J8
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Nova Scotia
Research Site
Sydney, Nova Scotia, Canada, B1S 3N1
Canada, Ontario
Research Site
Bowmanville, Ontario, Canada, L1C 1P6
Research Site
Brampton, Ontario, Canada, L6T 3J1
Research Site
Burlington, Ontario, Canada, L7R 4B7
Research Site
Burlington, Ontario, Canada, L7L 0B7
Research Site
Hamilton, Ontario, Canada, L8N 1Y2
Research Site
London, Ontario, Canada, N6A 4V2
Research Site
Mississauga, Ontario, Canada, L5M 2V8
Research Site
Newmarket, Ontario, Canada, L3Y 3R7
Research Site
Ottawa, Ontario, Canada, K1S 1C2
Research Site
St Catharines, Ontario, Canada, L2N 7E4
Research Site
Toronto, Ontario, Canada, M9C 5N2
Research Site
Toronto, Ontario, Canada, M9B 6H8
Research Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Research Site
Laval, Quebec, Canada, H7T 2P5
Research Site
Montreal, Quebec, Canada, H3T 1E2
Research Site
Montreal, Quebec, Canada, H2L 1S6
Research Site
Montreal, Quebec, Canada, H3Z 2Z3
Research Site
Rimouski, Quebec, Canada, G5L 8W1
Research Site
Saint Leonard, Quebec, Canada, H1R 1X8
Research Site
Saint-Eustache, Quebec, Canada, J7P 4J2
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada, S7K 0H6
Canada
Research Site
Quebec, Canada, G1V 3M7
Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00654368     History of Changes
Other Study ID Numbers: 20070301
Study First Received: April 3, 2008
Last Updated: October 9, 2013
Health Authority: Canada: Institutional Review Board

Keywords provided by Amgen:
Amgen

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on April 20, 2014