Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...
Brief Summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Options:
A: 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.
B: Inclusion Criteria:

* Adult patients, ≥ years of age.
* Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
* Receiving treatment on an outpatient basis.
* Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
* On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
* Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
* Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
* History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.

Other inclusion and exclusion criteria applied to the study.
C: Inclusion Criteria:

* Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP) \>3.2 or \>6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal
* At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor
* Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline
* Participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. Dose of methotrexate must be stable for at least 28 days prior to the first study dose (Day 1)
D: Inclusion Criteria:

* Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
* Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
* Patients eligible to begin conventional biologic therapy

Exclusion Criteria:

* Any criteria excluding treatment with biologic drugs according to international guidelines

Answer: A