Overview

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

Status:
Completed
Trial end date:
2016-09-16
Target enrollment:
0
Participant gender:
All
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 chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is 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

- 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

Exclusion Criteria:

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

- Unstable or progressive neurologic disorders