Back to resultsA Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
Primary Purpose
Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-42160443
JNJ-42160443
JNJ-42160443
Placebo
JNJ-42160443
JNJ-42160443
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Moderate to severe, osteoarthritis-related pain, Osteoarthritis-related pain, Moderate to severe chronic pain, JNJ-42160443
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
JNJ-42160443 1mg every 4 weeks
JNJ-42160443 3mg every 4 weeks
JNJ-42160443 3mg every 8 weeks
JNJ-42160443 6mg every 8 weeks
JNJ-42160443 10mg every 8 weeks
Matching placebo every 4 or 8 weeks
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the average osteoarthritis-related pain intensity score
Secondary Outcome Measures
Change from baseline in average OA-related pain intensity scores
Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1
Change from baseline in Pain severity and pain interference subscales of the BPI SF
Changes in PGA scores
Full Information
NCT ID
NCT00973141
First Posted
September 4, 2009
Last Updated
March 6, 2020
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00973141
Brief Title
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
Study Start Date
September 16, 2009 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
June 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Pain, Arthralgia, Joint Pain
Keywords
Moderate to severe, osteoarthritis-related pain, Osteoarthritis-related pain, Moderate to severe chronic pain, JNJ-42160443
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
467 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-42160443 1mg every 4 weeks
Arm Type
Experimental
Arm Title
JNJ-42160443 3mg every 4 weeks
Arm Type
Experimental
Arm Title
JNJ-42160443 3mg every 8 weeks
Arm Type
Experimental
Arm Title
JNJ-42160443 6mg every 8 weeks
Arm Type
Experimental
Arm Title
JNJ-42160443 10mg every 8 weeks
Arm Type
Experimental
Arm Title
Matching placebo every 4 or 8 weeks
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in the average osteoarthritis-related pain intensity score
Time Frame
At the end of the 12-week double-blind efficacy phase
Secondary Outcome Measure Information:
Title
Change from baseline in average OA-related pain intensity scores
Time Frame
At Weeks 4 and 8 and over the entire double-blind efficacy phase
Title
Change from baseline in Pain, stiffness, and function subscales of the WOMAC 3.1
Time Frame
At the end of the 12-week double-blind efficacy phase
Title
Change from baseline in Pain severity and pain interference subscales of the BPI SF
Time Frame
At the end of the 12-week double-blind efficacy phase
Title
Changes in PGA scores
Time Frame
At the end of the 12-week double-blind efficacy phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
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Birmingham
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Phoenix
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Tucson
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Carmichael
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Fresno
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Oldsmar
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Tampa
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Woodstock
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Boise
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Meridian
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Evansville
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Indianapolis
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Newburgh
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East Lansing
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Omaha
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Albuquerque
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Williamsville
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Raleigh
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Toledo
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Oklahoma City
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Odessa
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San Antonio
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Salt Lake City
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West Jordan
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Roanoke
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Spokane
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Burnaby
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Kamloops
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Kelowna
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Penticton
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St. John'S
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Newfoundland and Labrador
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Brampton
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Cambridge
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London
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Mississauga
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Newmarket
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Sarnia
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Montreal
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Sherbrooke
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Quebec
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Busan
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Korea, Republic of
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Dae-Gu
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Daegu
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Gwangju-Si
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Bialystok
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Elblag
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Gdynia
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Lublin
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Torun
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Warszawa
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Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27748055
Citation
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.
Results Reference
derived
Learn more about this trial
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
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