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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 3

Conditions

Osteoarthritis
Arthritis
Pain

Treatments

Biological: Tanezumab IV
Biological: Placebo IV
Biological: Tanezumab SC
Biological: Placebo SC

Study type

Interventional

Funder types

Industry

Identifiers

NCT01089725
A4091027
SC/IV OA STUDY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

385 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

385 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Biological: Placebo SC
Biological: Placebo IV
Biological: Placebo IV
Biological: Placebo SC
Biological: Placebo IV
Biological: Placebo IV
2.5 mg tanezumab SC and placebo IV
Experimental group
Treatment:
Biological: Tanezumab SC
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
5 mg tanezumab SC and placebo IV
Experimental group
Treatment:
Biological: Tanezumab SC
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
10 mg tanezumab SC and placebo IV
Experimental group
Treatment:
Biological: Tanezumab SC
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
Biological: Tanezumab SC
Biological: Placebo IV
Biological: Placebo IV
10 mg tanezumab IV
Experimental group
Treatment:
Biological: Tanezumab IV
Biological: Placebo SC
Biological: Placebo SC

Trial contacts and locations

90

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Data sourced from clinicaltrials.gov

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