Osteoarthritis, Pain
Conditions
Keywords
Osteoarthritis, Pain, Fulranumab, JNJ-42160443, Adjunctive therapy, Celecoxib, Hip, Knee, Joint replacement surgery
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.
Interventions
DRUGPlacebo
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.
DRUGFulranumab 1 mg
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.
DRUGFulranumab 3 mg
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.
DRUGCelecoxib 100 mg
Double-blind capsules taken twice daily for up to 16 weeks.
DRUGCelecoxib 100 mg Matching Placebo
Double-blind capsules taken twice daily for up to 16 weeks.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with Adverse Events as a measure of safety and tolerability | Up to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | See WOMAC 3.1 described above. |
| Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score | Baseline, Week 16 | 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). |
Countries
Australia, Canada, Czechia, Germany, Hungary, Poland, South Korea, Spain, Sweden, United Kingdom, United States
Outcome results
None listed