Conditions: Osteoarthritis
Keywords: Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 607
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

Detailed description:
This study was terminated on 16 Nov 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: IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 2: IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 3: IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 4: IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Interventions: intervention 1: tanezumab intervention 2: diclofenac intervention 3: tanezumab intervention 4: diclofenac intervention 5: tanezumab intervention 6: diclofenac intervention 7: diclofenac intervention 8: IV placebo
Intervention descriptions: intervention 1: IV tanezumab 10 mg every 8 weeks (through Week 16) intervention 2: Oral diclofenac SR 75 mg BID for 32 weeks intervention 3: IV tanezumab 5 mg every 8 weeks (through Week 16) intervention 4: Oral diclofenac SR 75 mg BID for 32 weeks intervention 5: IV tanezumab 2.5 mg every 8 weeks (through Week 16) intervention 6: Oral diclofenac SR 75 mg BID for 32 weeks intervention 7: Oral diclofenac SR 75 mg BID for 32 weeks intervention 8: IV placebo to match tanezumab every 8 weeks (through Week 16)

Protocol document: