Last updated date
ABOUT THIS STUDY
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have
previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624
on an open-label basis.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, OA Knee Pain, Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
40-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Enrolled in Study RN624-CL006
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- The occurrence of any adverse event or condition during the controlled studies that,
in the opinion of the Investigator, should exclude the subject from participating in
the open-label extension
- Pregnant or lactating female subjects or subjects who do not agree to use an
appropriate form of birth control throughout the study and for 3 months after
completing the study
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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Osteoarthritis, OA Knee Pain, ArthritisOpen-label Extension Study Of RN624
NCT00399490
- Birmingham, Alabama
- Birmingham, Alabama
- Phoenix, Arizona
- Anaheim, California
- Anaheim, California
- National City, California
- Stamford, Connecticut
- Stamford, Connecticut
- Daytona Beach, Florida
- Ocala, Florida
- Tampa, Florida
- Tampa, Florida
- Honolulu, Hawaii
- Boise, Idaho
- Merrillville, Indiana
- Louisville, Kentucky
- Wheaton, Maryland
- Worcester, Massachusetts
- Kansas City, Missouri
- Omaha, Nebraska
- Albuquerque, New Mexico
- Rochester, New York
- Greensboro, North Carolina
- Greensboro, North Carolina
- Zanesville, Ohio
- Duncansville, Pennsylvania
- Knoxville, Tennessee
- Knoxville, Tennessee
- Austin, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- Midvale, Utah
- Charlottesville, Virginia
- Yakima, Washington
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Open-label Extension Study Of RN624 | ||||||
| Official Title ICMJE | OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE. | ||||||
| Brief Summary | Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE | Drug: RN624 (PF-04383119)
50 mcg/kg | ||||||
| Study Arms ICMJE | Experimental: 1
Intervention: Drug: RN624 (PF-04383119) | ||||||
| Publications * | Schnitzer TJ, Lane NE, Birbara C, Smith MD, Simpson SL, Brown MT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage. 2011 Jun;19(6):639-46. doi: 10.1016/j.joca.2011.01.009. Epub 2011 Jan 18. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 287 | ||||||
| Original Enrollment ICMJE | 150 | ||||||
| Actual Study Completion Date ICMJE | February 11, 2008 | ||||||
| Actual Primary Completion Date | February 11, 2008 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 40 Years to 75 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00399490 | ||||||
| Other Study ID Numbers ICMJE | A4091009 RN624-CL007 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||