Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Brief Summary: This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Options:
A: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening
* Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening
* Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline
* C-Reactive Protein greater than or equal to 1.0 mg/dL at screening
* No history of latent or active tuberculosis prior to screening

Exclusion Criteria:

* Other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease
* Treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent
* Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent
* Known allergy to human immunoglobulin proteins or other components of golimumab
* Received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept
B: Inclusion Criteria:

* adult patients, ≥ 18 years of age;
* moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) \> 4.4);
* inadequate response to methotrexate;
* on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

Exclusion Criteria:

* prior treatment with a biologic;
* Rheumatoid arthritis (RA) functional class IV;
* known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
* evidence of active malignant disease.
C: Inclusion Criteria:

* Adult patients, ≥ 18 to \< 65 years of age
* Rheumatoid Arthritis (RA) of \> 6 months duration at baseline (American College of Rheumatology criteria)
* Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines
* Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years
* Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral)
* Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline
* Oral corticosteroids must be at stable dose of \< 10 mg/day prednisone or equivalent
* Body weight ≤ 150 kg at screening

Exclusion Criteria:

* Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 8 weeks after baseline
* History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
* Pre-existing central nervous system demyelinating or seizure disorders
* Active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections
* Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
* Active tuberculosis requiring treatment within 3 years prior to baseline
* Primary or secondary immunodeficiency (history or currently active)
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
D: Inclusion Criteria:

* Have a diagnosis of RA for at least 3 months prior to screening
* Have no history of latent or active tuberculosis (TB) and test negative for TB

Exclusion Criteria:

* Have inflammatory diseases other than RA
* Have been treated with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than methotrexate (MTX), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent
* Have received intramuscular (IM), IV, or intra-articular corticosteroids within 4 weeks of study agent administration
* Have a known hypersensitivity to human Ig proteins
* Have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent
* Have received alefacept, efalizumab, natalizumab, rituximab, or any B-cell-depleting agent
* Have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent
* Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, prior to screening
* Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
* Have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)

Answer: C