Open-label Extension Study Of RN624

NCT00399490

Last updated date
Study Location
BrookWood Internal Medicine
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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
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

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Osteoarthritis, OA Knee Pain, ArthritisOpen-label Extension Study Of RN624
NCT00399490
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Phoenix, Arizona
  4. Anaheim, California
  5. Anaheim, California
  6. National City, California
  7. Stamford, Connecticut
  8. Stamford, Connecticut
  9. Daytona Beach, Florida
  10. Ocala, Florida
  11. Tampa, Florida
  12. Tampa, Florida
  13. Honolulu, Hawaii
  14. Boise, Idaho
  15. Merrillville, Indiana
  16. Louisville, Kentucky
  17. Wheaton, Maryland
  18. Worcester, Massachusetts
  19. Kansas City, Missouri
  20. Omaha, Nebraska
  21. Albuquerque, New Mexico
  22. Rochester, New York
  23. Greensboro, North Carolina
  24. Greensboro, North Carolina
  25. Zanesville, Ohio
  26. Duncansville, Pennsylvania
  27. Knoxville, Tennessee
  28. Knoxville, Tennessee
  29. Austin, Texas
  30. San Antonio, Texas
  31. San Antonio, Texas
  32. San Antonio, Texas
  33. San Antonio, Texas
  34. Midvale, Utah
  35. Charlottesville, Virginia
  36. 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
  • Osteoarthritis
  • OA Knee Pain
  • Arthritis
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
 (submitted: January 11, 2021)
287
Original Enrollment  ICMJE
 (submitted: November 14, 2006)
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:

  • Enrolled in Study RN624-CL006

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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