Clinical trial NCT02301234: Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Pain
Keywords: Osteoarthritis
Pain
Fulranumab
JNJ-42160443
Adjunctive therapy
Celecoxib
Hip
Knee
Joint replacement surgery
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 111
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 signs and symptoms of osteoarthritis of the hip or knee that are 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. In addition, participants may elect to receive adjunctive therapy (ie, double-blind supplemental oral analgesic medication or matching placebo) throughout the double-blind treatment period. 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
* 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

Primary outcomes:
measure: The number of participants with Adverse Events as a measure of safety and tolerability
timeFrame: Up to Week 52
Secondary 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
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Elkridge
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Norman
country: United States
state: Oklahoma
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Tullahoma
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lampasas
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Camperdown
country: Australia
city: Hobart
country: Australia
city: Kippa Ring
country: Australia
city: Kogarah
country: Australia
city: Maroochydore
country: Australia
city: Melbourne
country: Australia
city: Sherwood
country: Australia
city: Kamloops
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: West Vancouver
country: Canada
city: Praha
country: Czechia
city: Leipzig
country: Germany
city: Szekszard
country: Hungary
city: Anyang
country: Korea, Republic of
city: Jeju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Elblag
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Warszaw
country: Poland
city: Wroclaw
country: Poland
city: A Coruña
country: Spain
city: Santiago De Compostela
country: Spain
city: Lund
country: Sweden
city: Malmo
country: Sweden
city: Blackpool
country: United Kingdom
city: Cannock
country: United Kingdom
city: Mancheter
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.