Overview

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

Status:
Completed
Trial end date:
2016-09-19
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 signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Antibodies, Monoclonal
Celecoxib
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

- 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 Criteria:

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

- Unstable or progressive neurologic disorders