Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
3 other identifiers
interventional
41
8 countries
28
Brief Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedStudy Start
First participant enrolled
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2016
CompletedApril 29, 2025
April 1, 2025
1.3 years
November 10, 2014
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
Baseline, Week 16
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score
See WOMAC 3.1 described above.
Baseline, Week 16
Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
Baseline, Week 16
Secondary Outcomes (9)
Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
Baseline, Week 16
Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score
Baseline, Week 16
Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score
Baseline, Week 16
Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores
Baseline, Week 16
Change from baseline to the end of Week 16 in Short-Form--36 (SF-36) subscale scores
Baseline, Week 16
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase.
Fulranumab 1 mg
EXPERIMENTALParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase.
Fulranumab 3 mg
EXPERIMENTALParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase.
Interventions
Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Eligibility Criteria
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
- Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
El Cajon, California, United States
Unknown Facility
Sherman Oaks, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Traverse City, Michigan, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Leuven, Belgium
Unknown Facility
Newmarket, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Prague, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Almere Stad, Netherlands
Unknown Facility
Bialystok, Poland
Unknown Facility
Gdynia, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Zgierz, Poland
Unknown Facility
Alcalá de Henares, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Blackpool, United Kingdom
Unknown Facility
Cannock, United Kingdom
Unknown Facility
Mancheter, United Kingdom
Unknown Facility
Stourton, United Kingdom
Related Publications (1)
Kelly KM, Sanga P, Zaki N, Wang S, Haeussler J, Louie J, Thipphawong J. Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies. Curr Med Res Opin. 2019 Dec;35(12):2117-2127. doi: 10.1080/03007995.2019.1653068. Epub 2019 Sep 13.
PMID: 31387410DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 13, 2014
Study Start
July 10, 2015
Primary Completion
October 10, 2016
Study Completion
October 10, 2016
Last Updated
April 29, 2025
Record last verified: 2025-04