Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia
Brief Summary: Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis


Options:
A: 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
B: Inclusion Criteria:

* Subjects must be at least 18 years old at the screening visit
* Subjects must be able to understand the information provided to them and to give written informed consent, and be able and willing to comply with the study requirements
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide. Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 10 weeks after the last dose of CZP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for 10 weeks after the subject receives their last dose of CZP
* Subjects must have a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 6-months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria
* Subjects must have active RA disease as defined by: ≥ 4 tender joints (28 joint count) at Screening and Week 0; and ≥ 4 swollen joints (28 joint count) at Screening and Week 0

Exclusion Criteria:

* Subjects who have a diagnosis of any other inflammatory arthritis (eg., psoriatic arthritis or ankylosing spondylitis)
* Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ
* Subjects must be free of defined prohibited medication and biological therapy
* Subjects who have received any experimental nonbiological therapy, within or outside of a clinical trial in the 3 months prior to Week 0
* Subjects who have received any experimental biological agent in the past 3 months or within 5 half-lives prior to Week 0 (whichever is longer)
* Subjects who have received previous treatment with biological response modifier therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
* Subjects with a history of pneumococcal or influenza infection in the last 3 months
* Subjects with a history of pneumococcal vaccination in the last 5 years
* Subjects with a history of influenza vaccination within the last 6 months
* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the trial or within 3 months following last dose of study drug
* Subjects with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection
* Subjects who have had a splenectomy
* Subjects who have had a hypersensitivity reaction to previous pneumococcal or influenza vaccination
* Subjects who have a known hypersensitivity to eggs and egg products or to other components of the vaccine
* Subjects with a history of Guillain-Barre syndrome
* Subjects with a history of tuberculosis, active tuberculosis, positive chest x-ray for tuberculosis, or positive purified protein derivative (PPD) skin test (defined as induration of ≥5 mm). Subjects who are not candidates for PPD testing due to prior severe reaction to the PPD test or a history of PPD positivity must undergo an Elispot test instead for tuberculosis evaluation. Subjects testing positive via the PPD or having an indeterminate or positive Elispot test, or for which latent tuberculosis cannot be ruled out, may be enrolled in the study provided that they are treated (eg., isoniazid for 9 months) and that their treatment has been initiated at least 4 weeks prior to the first administration of CZP
* Subjects at high risk of infection (eg., presence of leg ulcers or an indwelling urinary catheter, persistent or recurrent chest infections, bedridden or wheelchair bound subjects)
* Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease
* Subjects with known concurrent acute or chronic viral hepatitis B or C or positive hepatitis B surface antigen (HBs-Ag) or hepatitis C virus antibody (HCV-Ab)
* Subjects with known human immunodeficiency virus (HIV) infection
* Subjects receiving any live or attenuated vaccination within 12 weeks prior to Week 0
* Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to screening)
* Subjects with Class III or Class IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria
* Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg., multiple sclerosis or optic neuritis)
* Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
* Subjects with any other condition (eg., clinically significant laboratory values) which in the Investigator's judgement would make the subject unsuitable for inclusion in the study
* Subjects with a history of an adverse reaction to polyethylene glycol (PEG)
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:

* Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months

Exclusion Criteria:

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

Answer: A