Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Brief Summary: To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.


Options:
A: Inclusion Criteria:

* Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
* Subjects must have active RA disease as defined by:

  * At least 6 tender joints and 6 swollen joints
  * ESR of 28 mm/hour or CRP of 2.0 mg/dL
* Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX)
* Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)

Exclusion Criteria:

* Patients who have a diagnosis of any other inflammatory arthritis
* Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
* Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
* Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
* Patients who currently have, or who have a history of, tuberculosis
* Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
* Patients who currently have, or who have a history of, malignancy
* Female patients who are breastfeeding or pregnant, who are of childbearing potential
* Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.
B: Inclusion Criteria:

* Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
* Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
* Active disease, defined as: CRP \>= 1.0 mg/dL; swollen joint count \>= 6 (66 joint count); tender joint count \>= 6 (68 joint count)
* Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
* For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
* For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study, or breastfeeding
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
* Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
* Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)
C: Inclusion Criteria

* Rheumatoid arthritis based on the American College of Rheumatology criteria
* Methotrexate or leflunomide naïve
* Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

* History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
* Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
* Joint surgery involving joints to be assessed within 8 weeks prior to Screening
D: 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.

Answer: C