Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors
Brief Summary: The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.


Options:
A: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF
B: Inclusion Criteria:

* Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:

  1. Subjects who developed RA within one year after onset of RA.
  2. Subjects who have never received MTX before (MTX naive)
  3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
  4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.

Exclusion Criteria:

* Patients who have a diagnosis of any other type of inflammatory arthritis.
* Patients who have a secondary, non-inflammatory type of arthritis.
* Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
* 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 have a history of, malignant tumor
* Female patients who are breastfeeding or pregnant, who are of childbearing potential
C: 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.
D: Inclusion Criteria:

* Subjects 18 years of age or older
* Subjects with a diagnosis of Adult-onset Rheumatoid Arthritis of at least 3 months as defined by the 1987 American College of Rheumatology (ACR) classification criteria
* Subjects with active Rheumatoid Arthritis as defined by:

  * 4 tender joints (28 joint count) at Screening and Baseline Visits; and
  * 4 swollen joints (28 joint count) at Screening and Baseline Visits
* Subjects who have had an unsatisfactory response or intolerance to at least 1 traditional Disease-modifying Antirheumatic Drugs (DMARD)

Exclusion Criteria:

* Subjects must not have a diagnosis of any other inflammatory Arthritis
* Subjects must not have greater than 3 Arthroplasties due to Rheumatoid Arthritis and/or Steinbrocker IV Functional Capacity
* Subjects must not have a secondary non-inflammatory type of Arthritis that would interfere with study evaluation
* Subjects must not be diagnosed with Fibromyalgia with sufficient symptoms requiring treatment
* Subjects must not have a history of Infected Joint Prosthesis
* Subjects must not have discontinued biological therapy for their Rheumatoid Arthritis due to Severe Hypersensitivity Reaction or Anaphylactic Reaction
* Subjects must not have received more than 2 anti- Tumor Necrosis Factor (TNF) agents prior to enrollment
* Subjects must not have received treatment with Abatacept and/or Rituximab or have received any experimental or approved B cell therapeutic agent
* Subjects must not have a history of chronic alcohol or drug abuse
* Subjects must not have known hypersensitivity to any components of the investigational medicinal product
* Subjects must not have a history of chronic infections, recent serious or life-threatening infection within 6 months or any current sign or symptom that may indicate an infection
* Subjects must not have a history of a Blood Dyscrasias
* Subjects with known Tuberculosis (TB) Disease, high risk of acquiring TB or latent TB infection
* Subjects must not be at high risk of infection
* Subjects must not have a history of Lymphoproliferative Disorder including Lymphoma signs and symptoms suggestive of Lymphoproliferative Disease
* Subjects must not have concurrent acute or chronic Viral Hepatitis B or C
* Subjects must not have known Human Immunodeficiency Virus (HIV) infection
* Subject must not have concurrent Malignancy or history of Malignancy
* Subjects must not have a current or recent history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
* Subjects must not have Class III or IV Congestive Heart Failure
* Subjects must not have history of, or suspected Demyelinating Disease of the Central Nervous System
* Subjects must not have a history of adverse reaction to Polyethylene Glycol (PEG)
* Subjects must not have significant laboratory abnormalities which in the investigators judgment would make the subject unsuitable for inclusion
* Subjects must not have a known history or clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, Nontuberculous Mycobacteria, Blastomyces or Aspergillus
* Subject must not have a known history of or be currently diagnosed with Systemic Lupus Erythematosus

Answer: B