Status:
COMPLETED
Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
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 adjunctive therapy compared with placebo in participants with signs and symptoms of osteoarthritis o...
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
- Unsatisfactory response (inadequate efficacy or poor tolerability) on local standard of care that includes 3 medications from at least 2 of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid). For participants in the USA and Canada only: 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 :
March 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2016
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT02301234
Start Date
March 25 2015
End Date
September 19 2016
Last Update
September 14 2017
Active Locations (64)
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1
Glendale, Arizona, United States
2
Phoenix, Arizona, United States
3
Tucson, Arizona, United States
4
Little Rock, Arkansas, United States