Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Pain

In brief

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 of the hip or knee that are not adequately controlled by current pain therapy.

Key facts

Study ID

NCT02301234

Run by

Janssen Research & Development, LLC

People needed

111

Starts

2015-03-25

Expected to finish

2016-09-19

Last updated by the study team

2017-09-14

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Garden Grove, California, United States
• Study site — Los Angeles, California, United States
• Study site — North Hollywood, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Coral Gables, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Elkridge, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Norman, Oklahoma, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Memphis, Tennessee, United States
• Study site — Tullahoma, Tennessee, United States
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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