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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2009

Last Updated Date

October 1, 2012

Start Date ^ICMJE

November 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00994890 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Osteoarthritis, Knee
Osteoarthritis, Hip

Intervention ^ICMJE

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
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
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

Study Arm (s)

Experimental: Tanezumab 2.5 mg
Intervention: Biological: Tanezumab 2.5 mg
Experimental: Tanezumab 5 mg
Intervention: Biological: Tanezumab 5 mg
Experimental: Tanezumab 10 mg
Intervention: Biological: Tanezumab 10 mg

Publications *

Not Provided

* 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

Enrollment ^ICMJE

679

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00994890

Other Study ID Numbers ^ICMJE

A4091043

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2012

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

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