Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
NCT ID: NCT00960804
Last Updated: 2021-02-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
21 participants
INTERVENTIONAL
2010-02-15
2010-11-11
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
DOUBLE
Study Groups
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Tanezumab 5 mg
Tanezumab
IV, 5 mg dose, q 8 weeks, for up to 80 weeks
Tanezumab 10 mg
Tanezumab
IV, 10 mg dose, q 8 weeks, for up to 80 weeks
Placebo
Placebo
IV, q 8 weeks, for up to 80 weeks
Interventions
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Tanezumab
IV, 5 mg dose, q 8 weeks, for up to 80 weeks
Tanezumab
IV, 10 mg dose, q 8 weeks, for up to 80 weeks
Placebo
IV, q 8 weeks, for up to 80 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
* Patients must have participated in the A4091026 study.
Exclusion Criteria
* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Jem Research, LLC
Atlantis, Florida, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
Clinical Physiology Associates, Clinical Study Center
Fort Myers, Florida, United States
Harris Bonnette, MD
Fort Myers, Florida, United States
Arthritis & Rheumatic Care Center
South Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Neuroscience Consultants, LLC
South Miami, Florida, United States
Asheville Imaging
Asheville, North Carolina, United States
Biltmore Medical Associates
Asheville, North Carolina, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
Asheville Neurology
Asheville, North Carolina, United States
Ohio Research Center
Toledo, Ohio, United States
Blair Neurologic Associates
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, United States
Tidewater Neurology
Goose Creek, South Carolina, United States
Neurodiagnostic Laboratories of San Antonio, Inc
San Antonio, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NERVE FUNCTION EXTENSION STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091040
Identifier Type: -
Identifier Source: org_study_id
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