Conditions: Osteoarthritis Arthritis
Keywords: monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN624 osteoarthritis (OA)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2720
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: Oral NSAID arm 2: IV tanezumab 5 mg every 8 weeks (through Week 48) arm 3: IV tanezumab 10 mg every 8 weeks (through Week 48) arm 4: 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 arm 5: 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

Interventions: intervention 1: NSAID intervention 2: tanezumab intervention 3: tanezumab intervention 4: tanezumab intervention 5: NSAID intervention 6: tanezumab intervention 7: NSAID
Intervention descriptions: intervention 1: IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks intervention 2: IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56 intervention 3: IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56 intervention 4: IV tanezumab 5 mg every 8 weeks (through Week 48) intervention 5: Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks intervention 6: IV tanezumab 10 mg every 8 weeks (through Week 48) intervention 7: Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Protocol document: