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:

* The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL.
* Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
* Patient must remain on at least one background traditional disease modifying antirheumatic drug.
* No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L.
* History of any other rheumatic autoimmune 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.
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:

* Diagnosis of Rheumatoid Arthritis (RA)
* Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
* Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
* Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
D: 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.

Answer: D