Status:
COMPLETED
Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 rheuma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01197066
Start Date
March 1 2010
End Date
November 1 2016
Last Update
June 10 2022
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