CAMEO: Canadian Methotrexate and Etanercept Outcome Study

NCT00654368

Last updated date
Study Location
Research Site
Vancouver, British Columbia, V5Z 3Y1, Canada
Contact
1-800-718-1021

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1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Biological: Etanercept
    Commercially available etanercept administered subcutaneously at 50 mg/week.
    Other Name: Enbrel®
  • Drug: Methotrexate
    Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
Study Arms  ICMJE
  • Active Comparator: Etanercept + Methotrexate
    After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
    Interventions:
    • Biological: Etanercept
    • Drug: Methotrexate
  • Experimental: Etanercept Only
    After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
    Interventions:
    • Biological: Etanercept
    • Drug: Methotrexate
Publications *

*   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
 (submitted: June 11, 2014)
258
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:MDAmgen
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