Status:
COMPLETED
Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Osteoarthritis
Pain
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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 h...
Detailed Description
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to...
Eligibility Criteria
Inclusion
- 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
- Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
- Unstable or progressive neurologic disorders
Key Trial Info
Start Date :
July 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02289716
Start Date
July 10 2015
End Date
October 10 2016
Last Update
April 29 2025
Active Locations (28)
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1
El Cajon, California, United States
2
Sherman Oaks, California, United States
3
Miami, Florida, United States
4
Traverse City, Michigan, United States