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

Overview

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.

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: June 30, 2011

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).

Interventions

• 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: Placebo
  • Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.
• 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).

Arms, Groups and Cohorts

• Experimental: JNJ-42160443 1mg every 4 weeks
• Experimental: JNJ-42160443 3mg every 4 weeks
• Experimental: JNJ-42160443 3mg every 8 weeks
• Experimental: JNJ-42160443 6mg every 8 weeks
• Experimental: JNJ-42160443 10mg every 8 weeks
• Placebo Comparator: Matching placebo every 4 or 8 weeks

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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
• 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
• 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
• Changes in PGA scores
  • Time Frame: At the end of the 12-week double-blind efficacy phase

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.