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Trial record 1 of 1 for:    NCT00809783
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Extension Study Of Tanezumab In Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00809783
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 17, 2008
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE February 6, 2009
Actual Primary Completion Date November 2, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • Hematology [ Time Frame: 112 weeks ]
  • Electrocardiogram [ Time Frame: 112 weeks ]
  • Clinical Chemistry [ Time Frame: 112 weeks ]
  • Adverse Events [ Time Frame: 112 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Hematology [ Time Frame: 1 year ]
  • Electrocardiagram [ Time Frame: 1 year ]
  • Clinical Chemistry [ Time Frame: 1 year ]
  • Adverse Events [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • Womac Pain [ Time Frame: 112 weeks ]
  • Womac Physical Function [ Time Frame: 112 weeks ]
  • Womac Stiffness [ Time Frame: 112 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Womac Pain [ Time Frame: 1 year ]
  • Womac Physical Function [ Time Frame: 1 year ]
  • Womac Stiffness [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study Of Tanezumab In Osteoarthritis
Official Title  ICMJE A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Brief Summary Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
Detailed Description This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: tanezumab
    Tanezumab 10 mg
    Other Name: RN624
  • Biological: tanezumab
    Tanezumab 5 mg
    Other Name: RN624
  • Biological: tanezumab
    Tanezumab 2.5 mg
    Other Name: RN624
Study Arms  ICMJE
  • Experimental: Tanezumab 10 mg
    Tanezumab 10 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg
    Tanezumab 5 mg
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 2.5 mg
    Tanezumab 2.5 mg
    Intervention: Biological: tanezumab
Publications * Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 6, 2011)
2147
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
2400
Actual Study Completion Date  ICMJE June 23, 2011
Actual Primary Completion Date November 2, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

  • Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 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 NCT00809783
Other Study ID Numbers  ICMJE A4091016
P3 LONG TERM SAFETY EXTENSION ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP