CAMEO: Canadian Methotrexate and Etanercept Outcome Study

Amgen

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Biological: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654368

20070301

Details and patient eligibility

About

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

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

Etanercept + Methotrexate

Active Comparator group

Description:

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.

Treatment:

Biological: Etanercept

Drug: Methotrexate

Etanercept Only

Experimental group

Description:

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.

Treatment:

Biological: Etanercept

Drug: Methotrexate