Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Inclusion Criteria

* Subject must be 18 or older and in good health
* Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
* Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
* Subject must fulfill at least one of the following three criteria:

  * Rheumatoid factor positive
  * Greater than 1 joint erosion
  * Anti-cyclic citrullinated peptide (CCP) antibody positive.

Exclusion Criteria

* Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
* Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
* Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
B: Inclusion Criteria:

* adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to a stable dose of MTX;
* 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 surgery within 6 months after entering study;
* prior treatment failure with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
C: Inclusion Criteria:

* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/L
* History of any other autoimmune rheumatic disease other than Sjogren's syndrome
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
* Patients who have previously received adalimumab therapy for any reason.
* Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
* Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
D: Inclusion Criteria:

* Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials

Answer: A