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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Treatments: Certolizumab Pegol

Criteria

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