Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Adjunctive Therapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
3 other identifiers
interventional
79
6 countries
53
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 chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is 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
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedStudy Start
First participant enrolled
July 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2016
CompletedOctober 2, 2017
September 1, 2017
1.2 years
January 8, 2015
September 25, 2017
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 in addition to opioids as standard of care.
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 to opioids as standard of care.
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 to opioids as standard of care.
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.
Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
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Cerritos, California, United States
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Denver, Colorado, United States
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Stamford, Connecticut, United States
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Lewes, Delaware, United States
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Newark, Delaware, United States
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Crystal River, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Opa-locka, Florida, United States
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Port Orange, Florida, United States
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Marietta, Georgia, United States
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Woodstock, Georgia, United States
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Chicago, Illinois, United States
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Rockford, Illinois, United States
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Prairie Village, Kansas, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Frederick, Maryland, United States
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Worcester, Massachusetts, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Lake Success, New York, United States
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Oklahoma City, Oklahoma, United States
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Downingtown, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Jackson, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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West Jordan, Utah, United States
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Richmond, Virginia, United States
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Burlington, Ontario, Canada
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Sarnia, Ontario, Canada
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Baja, Hungary
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Szeged, Hungary
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Canterbury, New Zealand
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Newtown, New Zealand
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Takapuna, New Zealand
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Tauranga, New Zealand
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Bialystok, Poland
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Gdansk, Poland
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Myślenice, Poland
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Blackpool, United Kingdom
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Cannock, United Kingdom
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Greater Manchester, United Kingdom
Unknown Facility
Mancheter, United Kingdom
Unknown Facility
Matrix Park Buckshow Willage, 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
January 8, 2015
First Posted
January 13, 2015
Study Start
July 7, 2015
Primary Completion
September 16, 2016
Study Completion
September 16, 2016
Last Updated
October 2, 2017
Record last verified: 2017-09