Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study - Full Text View

Purpose

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

Condition	Intervention	Phase
Osteoarthritis Arthritis Pain	Biological: Placebo IV Biological: Placebo SC Biological: Tanezumab SC Biological: Tanezumab IV	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from Baseline to Week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain subscale [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 16 in the WOMAC Physical Function subscale [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 16 in the Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC Pain subscale change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
WOMAC Physical Function subscale change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis (5-point Likert scale) change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) and OsteoArthritis Research Society International (OARSI) responder index at Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Treatment Response: Reduction in the WOMAC Pain subscale of greater than or equal to: 30%, 50%, 70%, and 90% at Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score to Weeks 1, 2, 4, 8, 12 and 16 (endpoint for summary only) [ Time Frame: Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Treatment Response: Improvement of greater than or equal to 2 points in Patient Global Assessment of Osteoarthritis at Weeks 1, 2, 4, 8, 12, and 16 • [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Average pain score in the index knee change from Baseline to Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
WOMAC Stiffness subscale change from Baseline to Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
WOMAC Average change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface, change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs, change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
SF-36v2TM Health Survey change from Baseline to Week 16 (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
Time to discontinuation due to Lack of Efficacy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Incidence of patients who use rescue medication during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Number of days of rescue medication use during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Amount (mg) of rescue medication taken during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Clinical laboratory testing (chemistry, hematology, urinalysis) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Neurologic exam (Neuropathy Impairment Score [NIS]) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Anti Drug Antibody (ADA) assessments predose at Baseline, Week 8 and 16, and at Week 24, or Early Termination [ Time Frame: Baseline, Week 8 and 16, and at Week 24, or Early Termination ] [ Designated as safety issue: Yes ]
Physical examinations [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Injection/infusion site reactions [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Measurement of plasma tanezumab concentrations at Baseline (predose), Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16, and Week 24 or early termination [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16, and Week 24 ] [ Designated as safety issue: No ]
Measurement of serum total and/or bound and/or free NGF concentrations at Baseline (predose), Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16 and Week 24 or early termination [ Time Frame: Baseline , Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16 and Week 24 ] [ Designated as safety issue: Yes ]

Enrollment:	385
Study Start Date:	March 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Biological: Placebo IV 1 ml of placebo administered SC and IV once every 8 weeks. Biological: Placebo SC 1 ml of placebo administered SC and IV once every 8 weeks.
Experimental: 2.5 mg tanezumab SC and placebo IV	Biological: Tanezumab SC 1 ml tanezumab injection SC administered every 8 weeks Biological: Placebo IV 1 ml placebo administered IV every 8 weeks
Experimental: 5 mg tanezumab SC and placebo IV	Biological: Tanezumab SC 1 ml tanezumab injection SC administered every 8 weeks Biological: Placebo IV 1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab SC and placebo IV	Biological: Tanezumab SC 1 ml tanezumab injection SC administered every 8 weeks Biological: Placebo IV 1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab IV	Biological: Tanezumab IV 1 ml tanezumab injection IV administered every 8 weeks Biological: Placebo SC 1ml placebo administered SC every 8 weeks

Detailed Description:

This study was terminated on 08 Nov 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:

Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
18 years of age or greater
Two methods of birth control one of which must be barrier if of childbearing potential
Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria:

Pregnancy or wishing to be pregnant during the course of the study, lactating women
Body Mass Index (BMI) greater than 39
Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
Previous exposure to a Nerve Growth Factor (NGF) antibody

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089725

Show 80 Study Locations

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:	NCT01089725 History of Changes
Other Study ID Numbers:	A4091027
Study First Received:	March 11, 2010
Last Updated:	October 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

safety
efficacy
parallel group
double-blind
multicenter
injection

infusion
osteoarthritis
bridging
subcutaneous
intravenous
tanezumab

Additional relevant MeSH terms:

Arthritis
Osteoarthritis
Osteoarthritis, Knee

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013