Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT00753454
Last Updated: 2018-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2008-09-30
2011-05-31
Brief Summary
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Detailed Description
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All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDP870
Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).
Certolizumab pegol
Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks).
Interventions
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Certolizumab pegol
Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
* Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
* Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
* Patients must be willing to comply with protocol
Exclusion Criteria
* Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
* Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
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
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
San Diego, California, 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
Morton Grove, Illinois, United States
Vernon Hills, Illinois, United States
Lexington, Kentucky, United States
Haverhill, Massachusetts, United States
Worcester, Massachusetts, United States
Rochester, Minnesota, 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
Norman, Oklahoma, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2007-005267-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87084
Identifier Type: -
Identifier Source: org_study_id
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