A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol

To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.

Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Inclusion Criteria:

• Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
• Active RA
• Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
• Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance

Exclusion Criteria:

• Subject cannot have a second non-inflammatory musculoskeletal condition
• Subject cannot have a diagnosis of any other inflammatory arthritis
• Subject cannot have any previously infected prosthesis
• Subject cannot have arthroplasties in any of the joints assessed in the study
• Subject cannot have a history of chronic infections
• Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
• Subject cannot have a history of or current Lymphoproliferative disorder
• Subject cannot have known Human Immunodeficiency Virus (HIV) infection
• Subject cannot have received a live or attenuated vaccine within 8 weeks
• Subject cannot have current or history of malignancy
• Subject cannot have a history of blood disorders
• Subject cannot 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 a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin