Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
3 other identifiers
interventional
111
11 countries
64
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2015
64 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 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedStudy Start
First participant enrolled
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2016
CompletedSeptember 14, 2017
August 1, 2017
1.5 years
November 21, 2014
September 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of participants with Adverse Events as a measure of safety and tolerability
Up to Week 52
Secondary Outcomes (2)
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
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
Baseline, Week 16
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. In addition, participants may take adjunctive therapy with celecoxib 100 mg orally (by mouth) twice daily for up to 16 weeks.
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. In addition, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.
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. In addition, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.
Interventions
Placebo will be administered once every 4 weeks with or without adjunctive therapy for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
Double-blind capsules taken twice daily for up to 16 weeks.
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Unknown Facility
Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Garden Grove, California, United States
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Los Angeles, California, United States
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North Hollywood, California, United States
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Boulder, Colorado, United States
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Coral Gables, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Columbus, Georgia, United States
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Chicago, Illinois, United States
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Overland Park, Kansas, United States
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Elkridge, Maryland, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Norman, Oklahoma, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Tullahoma, Tennessee, United States
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Arlington, Texas, United States
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Houston, Texas, United States
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Lampasas, Texas, United States
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Nassau Bay, Texas, United States
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Sugar Land, Texas, United States
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Arlington, Virginia, United States
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Charlottesville, Virginia, United States
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Camperdown, Australia
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Hobart, Australia
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Kippa-Ring, Australia
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Kogarah, Australia
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Maroochydore, Australia
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Melbourne, Australia
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Sherwood, Australia
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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West Vancouver, Canada
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Prague, Czechia
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Leipzig, Germany
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Szekszárd, Hungary
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Elblag, Poland
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Katowice, Poland
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Krakow, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Anyang, South Korea
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Jeju City, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Santiago de Compostela, Spain
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Lund, Sweden
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Malmo, Sweden
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Blackpool, United Kingdom
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Cannock, United Kingdom
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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)
Intervention 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 21, 2014
First Posted
November 25, 2014
Study Start
March 25, 2015
Primary Completion
September 19, 2016
Study Completion
September 19, 2016
Last Updated
September 14, 2017
Record last verified: 2017-08