Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

Recruiting in Palo Alto (17 mi)

+499 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.

Eligibility Criteria

Inclusion Criteria

A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader

Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period

WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening

Treatment Details

Interventions

• NSAID (Non-Steroidal Anti-Inflammatory Drugs)
• Tanezumab (Monoclonal Antibodies)

Participant Groups

Group I: Tanezumab 5 mg Experimental Treatment 1 Intervention

Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks

Group II: Tanezumab 2.5 mg Experimental Treatment 1 Intervention

Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks

Group III: NSAID Active Control 1 Intervention

Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

NSAID is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction
• Postoperative pain management

🇺🇸 Approved in United States as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction
• Postoperative pain management
• Arthritis
• Menstrual cramps

🇨🇦 Approved in Canada as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction
• Postoperative pain management

🇯🇵 Approved in Japan as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction

🇨🇳 Approved in China as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction

🇨🇭 Approved in Switzerland as NSAIDs for:

• Pain relief
• Inflammation
• Fever reduction
• Postoperative pain management

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

American Family Medical Ocala, FL

Albuquerque Clinical Trials, Inc. Albuquerque, NM

Valley Medical Research/Valley Medical Primary Care Centerville, OH

ARC Clinical Research at Wilson Parke Austin, TX

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

References