Clinical trial NCT00654368: CAMEO: Canadian Methotrexate and Etanercept Outcome Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2008-04-08
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
timeFrame: Month 6 (randomization) and Month 12
Secondary outcomes:
measure: Disease Activity Score (DAS) 28 Response
timeFrame: Month 6, 12, 18 and 24
measure: Change From Baseline in Disease Activity Score 28 (DAS28)
timeFrame: Baseline and Month 6, 12, 18 and 24
measure: Drug Persistence
timeFrame: Month 6, 12, 18 and 24
measure: Change From Baseline in Modified Total Sharp Score (mTSS)
timeFrame: Baseline, Month 12 and Month 24
measure: Change From Baseline in Joint Erosion Score
timeFrame: Baseline, Month 12 and Month 24
measure: Change From Baseline in Joint Space Narrowing
timeFrame: Baseline, Month 12 and Month 24
measure: Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)
timeFrame: Month 6, 12, 18 and 24
measure: Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)
timeFrame: Month 6, 12, 18 and 24
measure: Change From Month 6 in Short Form 36 Health Survey (SF-36)
timeFrame: Month 6, 12, 18 and 24
measure: Change From Month 6 in Work Productivity and Activity Impairment (WPAI)
timeFrame: Month 6, 12, 18 and 24
measure: Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Month 6, 12, 18 and 24
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 25 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Quispamsis
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Sydney
country: Canada
facility: Research Site
state: Nova Scotia
city: Bowmanville
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: St Catharines
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Rimouski
country: Canada
facility: Research Site
state: Quebec
city: Saint Leonard
country: Canada
facility: Research Site
state: Quebec
city: Saint-Eustache
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Keystone 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.