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Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01127893
First received: May 20, 2010
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks


Condition Intervention Phase
Osteoarthritis
 Biological: Tanezumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of The Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Hematology [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Chemistry [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Western Ontario MacMaster (WOMAC) questionnaire Pain [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]
  • WOMAC Physical Function [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]
  • WOMAC Stiffness [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 10 mg Biological: Tanezumab
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
Experimental: Tanezumab 5 mg Biological: Tanezumab
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
Experimental: Tanezumab 2.5 mg Biological: Tanezumab
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Detailed Description:

This study was terminated on 29 September 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have participated in specific Phase 3 parent study

Exclusion Criteria:

  • Failed screening for parent study, pregnant women, lactating mothers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127893

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01127893     History of Changes
Other Study ID Numbers: A4091032
Study First Received: May 20, 2010
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013