Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.

Inclusion Criteria:

• Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
• Have a clear chest X-ray at the Entry visit
• Negative urine pregnancy test at the Entry
• Continue treatment on methotrexate

Exclusion Criteria:

• Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
• Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
• At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
• NYHA (New York Heart Association) Class III or IV congestive heart failure
• Current or history of tuberculosis
• History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
• History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
• High risk of infection
• Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug