Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis
NCT ID: NCT00717236
Last Updated: 2018-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1648 participants
INTERVENTIONAL
2008-07-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Certolizumab pegol (CZP)
Certolizumab pegol (CZP)
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo
Placebo
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Interventions
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Certolizumab pegol (CZP)
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
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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Birmingham, Alabama, United States
Montgomery, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Fullerton, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Sacramento, California, United States
Santa Barbara, California, United States
Santa Maria, California, United States
Tustin, California, United States
Westlake Village, California, United States
Whittier, California, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Trumbull, Connecticut, United States
Lewes, Delaware, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Delray Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
Atlanta, Georgia, United States
Coeur d'Alene, Idaho, United States
Idaho Falls, Idaho, United States
Maywood, Illinois, United States
Peoria, Illinois, United States
Rock Island, Illinois, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Covington, Louisiana, United States
Lake Charles, Louisiana, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Battle Creek, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Petoskey, Michigan, United States
Duluth, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
Voorhees Township, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Roslyn, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Monroe, North Carolina, United States
Wilmington, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Fairfield, Ohio, United States
Mayfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Wexford, Pennsylvania, United States
Charleston, South Carolina, United States
Jackson, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Yakima, Washington, United States
Clarksburg, West Virginia, United States
Glendale, Wisconsin, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Rimouski, Quebec, Canada
Trois-Rivires, Quebec, Canada
Calgary, , Canada
Mississauga, , Canada
Newmarket, , Canada
Sainte-Foy, , Canada
Amiens, , France
Cahors, , France
Corbeil-Essonnes, , France
Dreux, , France
Liévin, , France
Montpellier, , France
Mulhouse, , France
Nantes, , France
Orléans, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Saint-Priest-en-Jarez, , France
Bad Neuenahr, , Germany
Baden, , Germany
Berlin, , Germany
Chemnitz, , Germany
Cologne, , Germany
Dresden, , Germany
Duisburg, , Germany
Erfurt, , Germany
Erlangen, , Germany
Freiburg im Breisgau, , Germany
Friedrichroda, , Germany
Goslar, , Germany
Hamburg, , Germany
Hildesheim, , Germany
Hoyerswerda, , Germany
Jena, , Germany
Kiel, , Germany
Leipzig, , Germany
Mainz, , Germany
München, , Germany
Neuss, , Germany
Osnabrück, , Germany
Rostock, , Germany
Wiesbaden, , Germany
Zerbst, , Germany
Bologna, , Italy
Genova, , Italy
Iesi, , Italy
Modena, , Italy
Palermo, , Italy
Pisa, , Italy
Prato, , Italy
Siena, , Italy
Udine, , Italy
Apeldoorn, , Netherlands
Arnhem, , Netherlands
Leiden, , Netherlands
The Hague, , Netherlands
A Coruña, , Spain
Barcelona, , Spain
Madrid, , Spain
Murcia, , Spain
Oviedo, , Spain
Pontevedra, , Spain
Sabadell, , Spain
Salamanca, , Spain
San Cristóbal de La Laguna, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Torrelavega, , Spain
Countries
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References
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Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.
Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.
Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2008-005427-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87094
Identifier Type: -
Identifier Source: org_study_id
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