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

April 3, 2008
October 9, 2013
June 2008
December 2012   (final data collection date for primary outcome measure)
Disease Activity Severity 28 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The change in DAS28 from 6 month randomization to 12 months
DAS28 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00654368 on ClinicalTrials.gov Archive Site
  • 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
radiographic disease progression, physical functioning, QOL, treatment satisfication, productivity and safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CAMEO: Canadian Methotrexate and Etanercept Outcome Study
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)

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood samples

Probability Sample

Subjects with ACR diagnosis of RA on stable dose of methotrexate for at least 12 weeks ready to start etanercept per approved product monograph

Rheumatoid Arthritis
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 + Methotrexate
    Etanercept + Methotrexate
    Intervention: Biological: Etanercept
  • Etanercept Only
    Etanercept Only
    Intervention: Biological: Etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00654368
20070301
No
Amgen
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
Amgen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP