Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: 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)
B: Inclusion Criteria:

* Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.
* Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.

Exclusion Criteria:

* Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.
C: 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.
D: 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.

Answer: D