Study Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
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
3 other identifiers
interventional
467
4 countries
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedStudy Start
First participant enrolled
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2011
CompletedMarch 11, 2020
March 1, 2020
1.8 years
September 4, 2009
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the average osteoarthritis-related pain intensity score
At the end of the 12-week double-blind efficacy phase
Secondary Outcomes (4)
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
Changes in PGA scores
At the end of the 12-week double-blind efficacy phase
Study Arms (6)
JNJ-42160443 1mg every 4 weeks
EXPERIMENTALJNJ-42160443 3mg every 4 weeks
EXPERIMENTALJNJ-42160443 3mg every 8 weeks
EXPERIMENTALJNJ-42160443 6mg every 8 weeks
EXPERIMENTALJNJ-42160443 10mg every 8 weeks
EXPERIMENTALMatching placebo every 4 or 8 weeks
PLACEBO COMPARATORInterventions
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).
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
Pismo Beach, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Oldsmar, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Woodstock, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Newburgh, Indiana, United States
Unknown Facility
Valparaiso, Indiana, United States
Unknown Facility
West Des Moines, Iowa, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Mandeville, Louisiana, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
Hyannis, Massachusetts, United States
Unknown Facility
Watertown, Massachusetts, United States
Unknown Facility
East Lansing, Michigan, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Greenville, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Bedford, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Odessa, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
West Jordan, Utah, United States
Unknown Facility
Roanoke, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Burnaby, British Columbia, Canada
Unknown Facility
Kamloops, British Columbia, Canada
Unknown Facility
Kelowna, British Columbia, Canada
Unknown Facility
Penticton, British Columbia, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Brampton, Ontario, Canada
Unknown Facility
Cambridge, Ontario, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Newmarket, Ontario, Canada
Unknown Facility
Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Bialystok, Poland
Unknown Facility
Elblag, Poland
Unknown Facility
Gdynia, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Busan, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Gwangju, South Korea
Related Publications (1)
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.
PMID: 27748055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2009
First Posted
September 9, 2009
Study Start
September 16, 2009
Primary Completion
June 30, 2011
Study Completion
June 30, 2011
Last Updated
March 11, 2020
Record last verified: 2020-03