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

NCT ID: NCT00973141

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-16
• Study Completion Date: 2011-06-30

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).

Conditions

Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain; Arthralgia; Joint Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-42160443 1mg every 4 weeks

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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).

JNJ-42160443 3mg every 4 weeks

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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).

JNJ-42160443 3mg every 8 weeks

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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).

JNJ-42160443 6mg every 8 weeks

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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).

JNJ-42160443 10mg every 8 weeks

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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).

Matching placebo every 4 or 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

Placebo

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

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

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

Clearwater, Florida, United States

Jacksonville, Florida, United States

Oldsmar, Florida, United States

Port Orange, Florida, United States

Tampa, Florida, United States

Woodstock, Georgia, United States

Boise, Idaho, United States

Meridian, Idaho, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Newburgh, Indiana, United States

Valparaiso, Indiana, United States

West Des Moines, Iowa, United States

Prairie Village, Kansas, United States

Topeka, Kansas, United States

Louisville, Kentucky, United States

Baton Rouge, Louisiana, United States

Lake Charles, Louisiana, United States

Mandeville, Louisiana, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Rockville, Maryland, United States

Hyannis, Massachusetts, United States

Watertown, Massachusetts, United States

East Lansing, Michigan, United States

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Williamsville, New York, United States

Greenville, North Carolina, United States

Raleigh, North Carolina, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Duncansville, Pennsylvania, United States

Austin, Texas, United States

Bedford, Texas, United States

Dallas, Texas, United States

Odessa, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

West Jordan, Utah, United States

Roanoke, Virginia, United States

Spokane, Washington, United States

Burnaby, British Columbia, Canada

Kamloops, British Columbia, Canada

Kelowna, British Columbia, Canada

Penticton, British Columbia, Canada

St. John's, Newfoundland and Labrador, Canada

Brampton, Ontario, Canada

Cambridge, Ontario, Canada

Greater Sudbury, Ontario, Canada

London, Ontario, Canada

Mississauga, Ontario, Canada

Newmarket, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Bialystok, , Poland

Elblag, , Poland

Gdynia, , Poland

Lublin, , Poland

Torun, , Poland

Warsaw, , Poland

Busan, , South Korea

Daegu, , South Korea

Gwangju, , South Korea

Countries

United States; Canada; Poland; South Korea

References

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.

Reference Type: DERIVED

PMID: 27748055 (View on PubMed)

Other Identifiers

42160443PAI2004

Identifier Type: OTHER

Identifier Source: secondary_id

2009-009856-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016471

Identifier Type: -

Identifier Source: org_study_id