Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
NCT ID: NCT00160693
Last Updated: 2018-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
402 participants
INTERVENTIONAL
2003-03-31
2011-02-28
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
Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Interventions
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Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
* Must have provided written informed consent before undergoing any study procedures
Exclusion Criteria
* Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
* Any finding indicative of Tuberculosis at end of previous study
* Known HIV infection
* Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (\> 2 times upper limit of normal)
* Hemoglobin (Hgb) levels \< 9 g/dL or Hematocrit \< 30 %
* Total White Blood Cell (WBC) count of \< 3.0 x 100/L (\< 3000/mm\^3)
* Platelet count \< 100 x 100 L (100,000/mm\^3)
* Serum creatinine \> 1.5 times upper limit of normal based on patient age and sex
* Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
* Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
* Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Huntsville, Alabama, United States
Paradise Valley, Arizona, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Coeur d'Alene, Idaho, United States
Springfield, Illinois, United States
Wichita, Kansas, United States
Wheaton, Maryland, United States
Fall River, Massachusetts, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Erie, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Duncanville, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
San Diego, Texas, United States
Everett, Washington, United States
Graz, , Austria
Klagenfurt, , Austria
Vienna, , Austria
Antwerp, , Belgium
Diepenbeek, , Belgium
Liège, , Belgium
Merksem, , Belgium
České Budějovice, , Czechia
Liberec, , Czechia
Ostrava Trebovice, , Czechia
Prague, , Czechia
Praha4 -KRC, , Czechia
Uherské Hradiště, , Czechia
Berlin, , Germany
Cologne, , Germany
Gortlitz, , Germany
Hamburg, , Germany
Jena, , Germany
Leipzig, , Germany
Ratingen, , Germany
Dublin, , Ireland
Waterford, , Ireland
Birmingham, , United Kingdom
Cannock, , United Kingdom
Colchester, , United Kingdom
Glasgow, , United Kingdom
Harrogate, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Oxford, , United Kingdom
Peterborough, , United Kingdom
Countries
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References
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Fleischmann R, van Vollenhoven RF, Vencovsky J, Alten R, Davies O, Mountian I, de Longueville M, Carter D, Choy E. Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. Rheumatol Ther. 2017 Jun;4(1):57-69. doi: 10.1007/s40744-017-0060-8. Epub 2017 Mar 28.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2005-002617-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87015
Identifier Type: -
Identifier Source: org_study_id
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