Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis; Arthritis

Treatments: Biological: tanezumab; Drug: NSAID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809354

A4091025

2008-004815-37 (EudraCT Number)

OA CONTROLLED SAFETY STUDY (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Full description

This study was terminated on 28 October 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: 2,720 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
• Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
• Pain level and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
• Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion criteria

• Pregnant women.
• BMI greater than 39.
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
• Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
• Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
• History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
• At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
• Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
• Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,720 participants in 5 patient groups

IV Placebo + NSAID

Active Comparator group

Description:

Oral NSAID

Treatment:

Drug: NSAID

Drug: NSAID

Drug: NSAID

Tanezumab 5 mg

Experimental group

Description:

IV tanezumab 5 mg every 8 weeks (through Week 48)

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 10 mg

Experimental group

Description:

IV tanezumab 10 mg every 8 weeks (through Week 48)

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 5 mg + NSAID

Experimental group

Description:

IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Treatment:

Drug: NSAID

Biological: tanezumab

Biological: tanezumab

Drug: NSAID

Drug: NSAID

Biological: tanezumab

Biological: tanezumab

Tanezumab 10 mg + NSAID

Experimental group

Description:

IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Treatment:

Drug: NSAID

Biological: tanezumab

Biological: tanezumab

Drug: NSAID

Drug: NSAID

Biological: tanezumab

Biological: tanezumab