Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
Brief Summary: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.


Options:
A: Inclusion Criteria:

* Patients must be at least 18 years old at the screening visit.
* Patients must have a diagnosis of adult-onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.
* Patients must have active RA disease as defined by:

  * 9 tender joints at Screening and Baseline.
  * 9 swollen joints at Screening and Baseline. and fulfilling 1 of the following 2 criteria during the screening period:
  * 30 mm/hour ESR (Westergren), or CRP \>15 mg/L.
* Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
* Patients must be willing to complete an X-ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

Exclusion Criteria:

* Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
* Patients must not have a secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia)
* Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
* Patients with a history of tuberculosis or positive chest X-ray for tuberculosis or positive
* Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
* Patients with known human immunodeficiency virus (HIV) infection.
* Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).
* Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial.
* Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
B: 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
C: Inclusion Criteria:

* Male and female, aged at least 18 years old at the Screening visit.
* A clear chest X-ray within 3 months prior to Baseline visit.
* A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
* Active RA disease at Screening and Baseline as defined by:

  * ≥9 tender joints.
  * ≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
  * ≥30 mm/hour ESR (Westergren), or
  * CRP \>15 mg/L.
* Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
* Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.

Exclusion Criteria:

* A diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
* A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
* A history of an infected joint prosthesis at any time with prosthesis still in situ.
* Does not meet exclusionary concomitant medication criteria.
* A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
* Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
D: 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

Answer: B