CAMEO: Canadian Methotrexate and Etanercept Outcome Study
NCT00654368
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | CAMEO: Canadian Methotrexate and Etanercept Outcome Study | |||
Official Title ICMJE | 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) | |||
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 etanercept (50 mg/week subcutaneously [SC]) added to existing MTX therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses of MTX) at baseline and were followed for 6 months. After 6 months of therapy, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: either discontinue MTX (tapered over 6 weeks) and continue etanercept alone or continue both etanercept plus MTX for an additional 18 months. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Rheumatoid Arthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 258 | |||
Original Estimated Enrollment ICMJE | 250 | |||
Actual Study Completion Date ICMJE | February 2013 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00654368 | |||
Other Study ID Numbers ICMJE | 20070301 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |