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

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Pfizer

Status and phase

Terminated
Phase 2

Conditions

Osteoarthritis, Hip
Osteoarthritis, Knee

Treatments

Drug: Tanezumab 2.5 mg
Drug: Tanezumab 5 mg
Drug: Tanezumab 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00994890
A4091043
SC OA SAFETY STUDY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

679 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

679 participants in 3 patient groups

Tanezumab 2.5 mg
Experimental group
Treatment:
Drug: Tanezumab 2.5 mg
Tanezumab 5 mg
Experimental group
Treatment:
Drug: Tanezumab 5 mg
Tanezumab 10 mg
Experimental group
Treatment:
Drug: Tanezumab 10 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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