Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001

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 chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is not adequately controlled by current pain therapy.

Key facts

Study ID

NCT02336685

Run by

Janssen Research & Development, LLC

People needed

79

Starts

2015-07-07

Expected to finish

2016-09-16

Last updated by the study team

2017-10-02

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
• An unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids) and receiving an opioid at study entry; For participants in the USA and Canada: 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) and receiving an opioid (other than codeine or codeine combination products) at study entry
• 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 — Huntsville, Alabama, United States
• Study site — Cerritos, California, United States
• Study site — Denver, Colorado, United States
• Study site — Stamford, Connecticut, United States
• Study site — Lewes, Delaware, United States
• Study site — Newark, Delaware, United States
• Study site — Crystal River, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Opa-locka, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Rockford, Illinois, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Frederick, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Brooklyn, New York, United States
• Study site — Lake Success, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.