A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00994890

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	Other: Tanezumab 2.5 mg Other: Tanezumab 5 mg Other: Tanezumab 10 mg	Phase II

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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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	Other: 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	Other: 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	Other: 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:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00994890 History of Changes
Other Study ID Numbers:	A4091043
Study First Received:	October 12, 2009
Last Updated:	December 20, 2010
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 February 09, 2012