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)
1 other identifier
interventional
258
1 country
28
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Jun 2008
Longer than P75 for phase_4 rheumatoid-arthritis
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 8, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedJuly 23, 2014
July 1, 2014
4.5 years
April 3, 2008
February 10, 2014
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.
Month 6 (randomization) and Month 12
Secondary Outcomes (12)
Disease Activity Score (DAS) 28 Response
Month 6, 12, 18 and 24
Change From Baseline in Disease Activity Score 28 (DAS28)
Baseline and Month 6, 12, 18 and 24
Drug Persistence
Month 6, 12, 18 and 24
Change From Baseline in Modified Total Sharp Score (mTSS)
Baseline, Month 12 and Month 24
Change From Baseline in Joint Erosion Score
Baseline, Month 12 and Month 24
- +7 more secondary outcomes
Study Arms (2)
Etanercept + Methotrexate
ACTIVE COMPARATORAfter 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.
Etanercept Only
EXPERIMENTALAfter 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
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (28)
Research Site
Vancouver, British Columbia, V5Z 3Y1, Canada
Research Site
Victoria, British Columbia, V8P 5P6, Canada
Research Site
Victoria, British Columbia, V8V 3P9, Canada
Research Site
Winnipeg, Manitoba, R3A 1M3, Canada
Research Site
Quispamsis, New Brunswick, E2E 4J8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Research Site
Sydney, Nova Scotia, B1S 3N1, Canada
Research Site
Bowmanville, Ontario, L1C 1P6, Canada
Research Site
Brampton, Ontario, L6T 3J1, Canada
Research Site
Burlington, Ontario, L7R 4B7, Canada
Research Site
Hamilton, Ontario, L8N 1Y2, Canada
Research Site
London, Ontario, N6A 4V2, Canada
Research Site
Mississauga, Ontario, L5M 2V8, Canada
Research Site
Newmarket, Ontario, L3Y 3R7, Canada
Research Site
Ottawa, Ontario, K1S 1C2, Canada
Research Site
St. Catharines, Ontario, L2N 7E4, Canada
Research Site
Toronto, Ontario, M5G 1X5, Canada
Research Site
Toronto, Ontario, M9B 6H8, Canada
Research Site
Laval, Quebec, H7T 2P5, Canada
Research Site
Montreal, Quebec, H2L 1S6, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Montreal, Quebec, H3Z 2Z3, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Rimouski, Quebec, G5L 8W1, Canada
Research Site
Saint-Eustache, Quebec, J7P 4J2, Canada
Research Site
Saint-Léonard, Quebec, H1R 1X8, Canada
Research Site
Saskatoon, Saskatchewan, S7K 0H6, Canada
Related Publications (2)
Pope JE, Haraoui B, Thorne JC, Vieira A, Poulin-Costello M, Keystone EC. The Canadian methotrexate and etanercept outcome study: a randomised trial of discontinuing versus continuing methotrexate after 6 months of etanercept and methotrexate therapy in rheumatoid arthritis. Ann Rheum Dis. 2014 Dec;73(12):2144-51. doi: 10.1136/annrheumdis-2013-203684. Epub 2013 Aug 26.
PMID: 23979914BACKGROUNDKeystone EC, Pope JE, Thorne JC, Poulin-Costello M, Phan-Chronis K, Vieira A, Haraoui B; CAMEO Investigators. Two-year radiographic and clinical outcomes from the Canadian Methotrexate and Etanercept Outcome study in patients with rheumatoid arthritis. Rheumatology (Oxford). 2016 Feb;55(2):327-34. doi: 10.1093/rheumatology/kev338. Epub 2015 Sep 11.
PMID: 26361879DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 8, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
July 23, 2014
Results First Posted
June 13, 2014
Record last verified: 2014-07