Clinical trial NCT02289716: Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Pain
Keywords: Osteoarthritis
Pain
Fulranumab
JNJ-42160443
Monotherapy
Hip
Knee
Joint replacement surgery
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 41
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 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.

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 monotherapy (alone; not 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. 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
* 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

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: El Cajon
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Traverse City
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Cincinnati
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
city: Leuven
country: Belgium
city: Newmarket
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Praha
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Almere
country: Netherlands
city: Bialystok
country: Poland
city: Białystok
country: Poland
city: Gdynia
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zgierz
country: Poland
city: Alcalá De Henares
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santiago De Compostela
country: Spain
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.