A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

RA0064 is a Phase 4, multicenter, randomized, 52-week study. All eligible subjects will
receive open label Cimzia 400 mg at Weeks 0, 2 and 4, followed by Cimzia 200 mg every 2 weeks
at Weeks 6 to 50 for the treatment of moderate to severe rheumatoid arthritis. All subjects
will be assessed using the 2 assessment tools: the subject-based Routine Assessment of
Patient Index (RAPID3) and the investigator-based Clinical Disease Activity Index (CDAI)

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