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