Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.

Inclusion Criteria:

• Participation in CZP trial C87014 or C87011
• If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
• Must have provided written informed consent before undergoing any study procedures

Exclusion Criteria:

• History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
• Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
• Any finding indicative of Tuberculosis at end of previous study
• Known HIV infection
• Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
• Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
• Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
• Platelet count < 100 x 100 L (100,000/mm^3)
• Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
• Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
• Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
• Any other condition which the Principal Investigator judges would make patient unsuitable for study participation