Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Brief Summary: Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.


Options:
A: Inclusion Criteria:

* Diagnosis of RA
* Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
* Active RA at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a DMARD, other than MTX, at screening
* Receipt of any DMARD, other than MTX, within 3 months before screening
B: Inclusion Criteria:

* Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
* Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to \< 12.5mg/week are allowed if there is documented intolerance
* Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
* CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
* Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening

Exclusion Criteria:

* Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
* Wheelchair bound or bedridden.
* Disease modifying antirheumatic drugs (DMARDs) other than MTX.
* Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
* Treatment with other biologics within 4-24 weeks (depending on the biologic)
* History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
* Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
* Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
* Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
* History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
C: Inclusion Criteria:

* Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
* Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria:

* Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
* Received disease-modifying antirheumatic drugs (\[DMARDs\] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[IL\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
D: Inclusion Criteria:

* adult patients at least 18 years of age with active RA for at least 3 months;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
* treatment with methotrexate (MTX) within 6 months of entering study;
* patients who have stopped previous MTX treatment due to toxicity or lack of response;
* women who are pregnant or breast-feeding.

Answer: C