Clinical trial NCT02336685: Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Pain
Keywords: Osteoarthritis
Pain
Fulranumab
JNJ-42160443
Adjunctive therapy
Opioid
Hip
Knee
Joint replacement surgery
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as adjunctive therapy (in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. All participants will be allowed standard of care for OA pain during the double-blind treatment phase and must be taking an opioid at study entry and during the double-blind treatment phase. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.

Eligibility 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

Primary outcomes:
measure: Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in Short-Form-36 (SF-36) subscale scores
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scale score
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in the percentage of participants who are responders based on WOMAC pain and physical function subscale scores and PGA scale scores
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in the percentage of participants who are responders based on OMERACT-OARSI, MCII, and PASS scale scores
timeFrame: Baseline, Week 16
measure: Change from baseline to the end of Week 16 in the percentage of participants who use rescue medication and other osteoarthritis (OA) analgesia
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Cerritos
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Lewes
country: United States
state: Delaware
city: Newark
country: United States
state: Delaware
city: Crystal River
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Opa-locka
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Prairie Village
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Frederick
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Downingtown
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: West Jordan
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Burlington
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Baja
country: Hungary
city: Szeged
country: Hungary
city: Canterbury
country: New Zealand
city: Newtown
country: New Zealand
city: Takapuna
country: New Zealand
city: Tauranga
country: New Zealand
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Myslenice
country: Poland
city: Blackpool
country: United Kingdom
city: Cannock
country: United Kingdom
city: Greater Manchester
country: United Kingdom
city: Mancheter
country: United Kingdom
city: Matrix Park Buckshow Willage
country: United Kingdom
city: Stourton
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.