CAMEO: Canadian Methotrexate and Etanercept Outcome Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Methotrexate
Intervention description: Commercially available etanercept administered subcutaneously at 50 mg/week.; Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amgen

Summary:

      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 criteria:

        Inclusion Criteria:

          -  18 years of age or older at the baseline visit

          -  An American College of Rheumatology(ACR) diagnosis of rheumatoid arthritis with onset
             of symptoms of at least 6 months

          -  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 patient 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

          -  Participants not available for follow-up assessment or unable to comply with study
             procedures