Status:
COMPLETED
CAMEO: Canadian Methotrexate and Etanercept Outcome Study
Lead Sponsor:
Amgen
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Detailed Description
This noninferiority study was a multicenter, open-label, randomized trial of patients with rheumatoid arthritis (RA). Patients who did not have an adequate response to methotrexate (MTX) had etanercep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00654368
Start Date
June 1 2008
End Date
February 1 2013
Last Update
July 23 2014
Active Locations (28)
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1
Research Site
Vancouver, British Columbia, Canada, V5Z 3Y1
2
Research Site
Victoria, British Columbia, Canada, V8P 5P6
3
Research Site
Victoria, British Columbia, Canada, V8V 3P9
4
Research Site
Winnipeg, Manitoba, Canada, R3A 1M3