Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis
NCT ID: NCT01197066
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2010-03-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Certolizumab Pegol
Single Arm
Certolizumab Pegol
Certolizumab Pegol 200mg
Interventions
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Certolizumab Pegol
Certolizumab Pegol 200mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a clear chest X-ray at the Entry visit
* Negative urine pregnancy test at the Entry
* Continue treatment on methotrexate
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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YoungMo Kang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital
Other Identifiers
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101-KOA-0802i
Identifier Type: -
Identifier Source: org_study_id
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