A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Moderate to Severe Knee or Hip Pain From Osteoarthritis

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in patients with a diagnosis of osteoarthritis.

Study Overview

• Status: Terminated
• Conditions: Pain; Osteoarthritis; Joint Pain; Arthralgia; Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Drug: JNJ-42160443; Drug: JNJ-42160443; Drug: JNJ-42160443; Drug: JNJ-42160443; Drug: JNJ-42160443; Drug: Placebo

Detailed Description

This current study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. The duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).JNJ-42160443 (10 mg/mL) or matching placebo given as an subcutaneous (injection under the skin) (SC) once every 4 weeks will be administered in the study as 1 of 5 JNJ-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase).

• Study Type: Interventional
• Enrollment (Actual): 467
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
  • British Columbia
    • Burnaby, British Columbia, Canada
    • Kamloops, British Columbia, Canada
    • Kelowna, British Columbia, Canada
    • Penticton, British Columbia, Canada
  • Newfoundland and Labrador
    • St. John'S, Newfoundland and Labrador, Canada
  • Ontario
    • Brampton, Ontario, Canada
    • Cambridge, Ontario, Canada
    • London, Ontario, Canada
    • Mississauga, Ontario, Canada
    • Newmarket, Ontario, Canada
    • Sarnia, Ontario, Canada
    • Sudbury, Ontario, Canada
    • Toronto, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Sherbrooke, Quebec, Canada
• Korea, Republic of
  • Busan, Korea, Republic of
  • Dae-Gu, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gwangju-Si, Korea, Republic of
• Poland
  • Bialystok, Poland
  • Elblag, Poland
  • Gdynia, Poland
  • Lublin, Poland
  • Torun, Poland
  • Warszawa, Poland
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • California
    • Carmichael, California, United States
    • Fresno, California, United States
    • Garden Grove, California, United States
    • Pismo Beach, California, United States
    • Roseville, California, United States
    • San Diego, California, United States
  • Florida
    • Clearwater, Florida, United States
    • Jacksonville, Florida, United States
    • Oldsmar, Florida, United States
    • Port Orange, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Woodstock, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
    • Meridian, Idaho, United States
  • Indiana
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
    • Newburgh, Indiana, United States
    • Valparaiso, Indiana, United States
  • Iowa
    • West Des Moines, Iowa, United States
  • Kansas
    • Prairie Village, Kansas, United States
    • Topeka, Kansas, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
    • Lake Charles, Louisiana, United States
    • Mandeville, Louisiana, United States
    • Metairie, Louisiana, United States
    • New Orleans, Louisiana, United States
  • Maryland
    • Rockville, Maryland, United States
  • Massachusetts
    • Hyannis, Massachusetts, United States
    • Watertown, Massachusetts, United States
  • Michigan
    • East Lansing, Michigan, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • New York, New York, United States
    • Williamsville, New York, United States
  • North Carolina
    • Greenville, North Carolina, United States
    • Raleigh, North Carolina, United States
  • Ohio
    • Toledo, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
  • Texas
    • Austin, Texas, United States
    • Bedford, Texas, United States
    • Dallas, Texas, United States
    • Odessa, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
    • West Jordan, Utah, United States
  • Virginia
    • Roanoke, Virginia, United States
  • Washington
    • Spokane, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Diagnosis of osteoarthritis of the hip or the knee; Have an average daily pain intensity score of >=5 averaged over the last 3 days before treatment assignment; Receiving a stable dose of non-steroidal anti-inflammatory drugs for a minimum of 5 days each week for the 4 weeks before screening or a stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day or a stable dose of long acting opioids for the 4 weeks before screening; but not exceeding 200 mg oral morphine equivalents per day; Have a mini mental state examination score of >=26 at screening. Exclusion Criteria:History within the past year of any of the following: seizure disorder; intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, transient ischemic attack, meningitis; History of brain injury within the past 15 years consisting of >= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours; History of epilepsy or multiple sclerosis; Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), study joint pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm; Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-42160443 1mg every 4 weeks	Drug: JNJ-42160443; Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 3mg every 4 weeks	Drug: JNJ-42160443; Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 3mg every 8 weeks	Drug: JNJ-42160443; Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 6mg every 8 weeks	Drug: JNJ-42160443; Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Experimental: JNJ-42160443 10mg every 8 weeks	Drug: JNJ-42160443; Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).; Drug: JNJ-42160443; Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
Placebo Comparator: Matching placebo every 4 or 8 weeks	Drug: Placebo; Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the average osteoarthritis-related pain intensity score	At the end of the 12-week double-blind efficacy phase

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in PGA scores	At the end of the 12-week double-blind efficacy phase
Change from baseline in average OA-related pain intensity scores	At Weeks 4 and 8 and over the entire double-blind efficacy phase
Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1	At the end of the 12-week double-blind efficacy phase
Change from baseline in Pain severity and pain interference subscales of the BPI SF	At the end of the 12-week double-blind efficacy phase

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Sanga P, Katz N, Polverejan E, Wang S, Kelly KM, Haeussler J, Thipphawong J. Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study. Arthritis Rheumatol. 2017 Apr;69(4):763-773. doi: 10.1002/art.39943. Epub 2017 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2009
• Primary Completion (Actual): June 30, 2011
• Study Completion (Actual): June 30, 2011

Study Registration Dates

• First Submitted: September 4, 2009
• First Submitted That Met QC Criteria: September 4, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: JNJ-42160443; Moderate to severe chronic pain; Moderate to severe, osteoarthritis-related pain; Osteoarthritis-related pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: CR016471; 2009-009856-19 (EudraCT Number: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); 42160443PAI2004 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes