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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00994890
• Date of registration: 12/10/2009
• Primary sponsor: Pfizer
• Public title: A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
• Scientific 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
• Date of first enrolment: November 2009
• Target sample size: 679
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00994890
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis, Hip

Osteoarthritis, Knee

Intervention(s)

Biological: Tanezumab 10 mg

Biological: Tanezumab 2.5 mg

Biological: Tanezumab 5 mg

Primary Outcome(s)

Adverse events [Time Frame: Baseline to Week 64]

Anti-drug antibody concentrations [Time Frame: Baseline, Weeks 8, 24, 40, 56 and 64]

Electrocardiograms (ECGs) [Time Frame: Baseline, Weeks 2, 8, 24 and 56]

Neurologic examinations, Vital Signs and Injection Site Assessments [Time Frame: Baseline, Weeks 2, 4 ,8, 16, 24, 32, 40, 48, 56 and 64]

Safety laboratory testing [Time Frame: Day 1, Weeks 8, 16, 24, 40, 56 and 64]

Secondary Outcome(s)

Cumulative Distribution of Percent Change in WOMAC Pain [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

Incidence of patients who use concomitant analgesics for osteoarthritis [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

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]

OMERACT-OARSI Responder Index [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

Patient Global Assessment of Osteoarthritis [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

Time to discontinuation Due to Lack of Efficacy [Time Frame: Baseline to Week 64]

Treatment Response in Patient Global Assessment of Osteoarthritis [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

Treatment Response: Reduction in WOMAC Pain [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

WOMAC Average Score [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

WOMAC Pain [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

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]

WOMAC Pain Item: Pain When Walking on Flat Surface [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

WOMAC Physical Function [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

WOMAC Stiffness [Time Frame: Baseline , Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64]

Secondary ID(s)

A4091043

Source(s) of Monetary Support

Please refer to primary and secondary sponsors