Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy
Brief Summary: This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).


Options:
A: Inclusion Criteria:

* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
* Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

* Received any previous treatment with MTX
* Received any previous treatment with ETN or other tumour necrosis factor antagonist
B: 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
C: Inclusion Criteria:

* Male or female ≥18 and ≤80 years of age at time of screening
* Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
* Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) \> 3.2 and ≤ 5.1
* Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
* Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

* Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
* Class IV rheumatoid arthritis according to ACR revised response criteria
* Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
* Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
* Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
* No more than 4 injections of adalimumab
* No more than 8 (50 mg) injections of etanercept
* No more than 2 infusions of infliximab
* No more than 2 infusions of abatacept
* Additional inclusion (exclusion) criteria may apply
D: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Diagnosis of rheumatoid arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (RF) positivity, erythrocyte sedimentation rate (ESR) \>= 28 mm/1h or C-reactive protein (CRP) \>= 1.5 mg/dl

Exclusion Criteria:

* Chronic arthritis diagnosed before the age of 16
* Preceding treatment with MTX, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (DMARDs)
* Subject previously received anti-tumor necrosis factor (TNF) therapy
* Permanently wheelchair-bound or bedridden patients
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Answer: C