A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

Inclusion Criteria

• An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or by the legal representative
• Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgment of the Investigator
• Subject is male or female, and at least 18 years of age at the Screening Visit
• Subjects must have a diagnosis of adult onset Rheumatoid Arthritis RA of at least 6 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988).
• Subjects must have active RA disease as defined by:
• ≥6 tender joints at Screening and Baseline
• ≥6 swollen joints at Screening and Baseline
• Fulfilling 1 of the following 2 criteria during the Screening Period:
• European League Against Rheumatism (ESR) (Westergren) ≥30 mm/hour, or
• C-reactive protein (CRP) >15 mg/L
• Subjects must have a normal chest x ray within 3 months prior to the Baseline Visit
• Female subjects with childbearing potential should have a negative pregnancy test at Screening and at Baseline and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab Pegol (CZP).
• Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication
• Subjects must have received treatment with Methotrexate (MTX) (with or without folic acid) for at least 3 months prior to the Baseline Visit. The dose and route of administration of MTX must have been stable for at least 2 months prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10 mg weekly

Exclusion Criteria

Rheumatoid Arthritis disease-related exclusions:

• Subjects have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
• Subjects have a secondary, noninflammatory type of arthritis (eg, Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
• Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ
• Subjects have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity

Concomitant medication exclusions:

• Subjects must be free of prohibited medication, Analgesics (including Paracetamol and Acetominophen), NSAIDs /COX-2 Inhibitors, Oral corticosteroids, DMARDs, etc. as detailed in protocol Previous clinical studies and previous biological therapy exclusions
• Subjects have previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study
• Subjects have participated in another study of an investigational medicinal product (or a medical device) within the previous 3 months or are currently participating in another study of an investigational medicinal product (or a medical device)
• Subjects have received any experimental nonbiological therapy, within or outside a clinical study in the 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit
• Subjects have received any biological therapy for RA within 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit, except for Etanercept and Anakinra where only a 1 month washout prior to the Baseline Visit is necessary
• Subjects have received Rituximab or Tocilizumab
• Subjects have received Yunke (technetium-99 conjugated with methylene diphosphonate) other than for diagnostic purpose within 5 years prior to Baseline
• Subjects have received previous treatment with a biological therapy for RA that resulted in