Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol
Intervention description: 400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; America College of Rheumatology; Disease modifying anti-rheumatic drug; Certolizumab Pegol (CDP870)

Summary:

      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.
    

Eligibility criteria:

        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