Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003

• Status: Completed
• Trial end date: 2016-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ≥2) of the study joint

• Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint

• Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)

• Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA

• During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child

Exclusion Criteria:

• Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)

• Unstable or progressive neurologic disorders