Dosing Flexibility Study in Patients With Rheumatoid Arthritis
NCT ID: NCT00580840
Last Updated: 2018-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
333 participants
INTERVENTIONAL
2007-12-31
2011-03-31
Brief Summary
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Detailed Description
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At the Week 18 visit, subjects who were ACR20 (American College of Rheumatology 20% Improvement) responders at Week 16 will be randomized in a double-blinded way to receive either 400 mg CZP given every 4 weeks and placebo given every 4 weeks given as two injections (alternating CZP and placebo every two weeks) plus MTX, 200 mg CZP and placebo administered every 2 weeks (one injection of each) plus MTX, or Placebo administered as two injections every 2 weeks plus MTX. Non-responders will be withdrawn from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Certolizumab pegol 400 mg and placebo
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
Certolizumab pegol
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
Placebo
placebo (saline) administered as two injections every 2 weeks
Certolizumab pegol 200 mg and placebo
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
Certolizumab pegol
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
Placebo
placebo (saline) administered as two injections every 2 weeks
Placebo
Placebo administered as two injections every 2 weeks
Placebo
placebo (saline) administered as two injections every 2 weeks
Interventions
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Certolizumab pegol
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
Certolizumab pegol
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
Placebo
placebo (saline) administered as two injections every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial
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
Locations
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Huntsville, Alabama, United States
Montgomery, Alabama, United States
Gilbert, Arizona, United States
Paradise Valley, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Huntington Beach, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Sacramento, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Sarasota, Florida, United States
Bogart, Georgia, United States
Morton Grove, Illinois, United States
Vernon Hills, Illinois, United States
Lexington, Kentucky, United States
Portland, Maine, United States
Haverhill, Massachusetts, United States
Pittsfield, Massachusetts, United States
Worcester, Massachusetts, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Albany, New York, United States
Mineola, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Monroe, North Carolina, United States
Wilmington, North Carolina, United States
Cleveland, Ohio, United States
Perrysburg, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Simpsonville, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Tyler, Texas, United States
Vancouver, Washington, United States
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Burlington, Ontario, Canada
Saint Catherine's, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Bobigny, , France
Le Havre, , France
Lille, , France
Limoges, , France
Montivilliers, , France
Nice, , France
Paris, , France
Perpigan, , France
Saint-Etienne, , France
Countries
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References
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Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2007-005288-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87077
Identifier Type: -
Identifier Source: org_study_id
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