A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00994890
First received: October 12, 2009
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.


Condition Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Biological: Tanezumab 2.5 mg
Biological: Tanezumab 5 mg
Biological: Tanezumab 10 mg
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: Yes ]
  • Safety laboratory testing [ Time Frame: Day 1, Weeks 8, 16, 24, 40, 56 and 64 ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) [ Time Frame: Baseline, Weeks 2, 8, 24 and 56 ] [ Designated as safety issue: Yes ]
  • Neurologic examinations, Vital Signs and Injection Site Assessments [ Time Frame: Baseline, Weeks 2, 4 ,8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: Yes ]
  • Anti-drug antibody concentrations [ Time Frame: Baseline, Weeks 8, 24, 40, 56 and 64 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • WOMAC Physical Function [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • WOMAC Stiffness [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • OMERACT-OARSI Responder Index [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Treatment Response: Reduction in WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Cumulative Distribution of Percent Change in WOMAC Pain [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Treatment Response in Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • WOMAC Average Score [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • WOMAC Pain Item: Pain When Walking on Flat Surface [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • WOMAC Pain Item: Pain When Going up or Down Stairs [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Time to discontinuation Due to Lack of Efficacy [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Incidence of patients who use concomitant analgesics for osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]
  • Number of days per week of use of concomitant analgesic medication for osteoarthritis [ Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ] [ Designated as safety issue: No ]

Enrollment: 679
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 2.5 mg Biological: Tanezumab 2.5 mg
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Other Name: Biological
Experimental: Tanezumab 5 mg Biological: Tanezumab 5 mg
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Other Name: Biological
Experimental: Tanezumab 10 mg Biological: Tanezumab 10 mg
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Other Name: Biological

Detailed Description:

Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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:

  • Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

Exclusion Criteria:

  • Body mass index (BMI) of >39 kg/m2;
  • Pregnancy or intent to become pregnant
  • Planned surgical procedure during the duration of the study
  • History of clinically significant cardiovascular, central nervous system or psychiatric disease
  • Previous exposure to exogenous NGF or to an anti NGF antibody;
  • Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994890

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00994890     History of Changes
Other Study ID Numbers: A4091043
Study First Received: October 12, 2009
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Double-blind safety

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

ClinicalTrials.gov processed this record on April 17, 2014