OsteoarthritisPhase 2NCT00973141
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
A Phase 2 study testing JNJ-42160443 in people with Osteoarthritis and Osteoarthritis, Hip, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 77 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- JNJ-42160443
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 467 participants
- Where
- 77 sitesin 4 countries
- Study dates
- 16 Sep 2009to 30 Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
77 sites in 4 countries.
77 sites in 4 countries
United States52 sites
Study site
Albuquerque, New Mexico
Study site
Austin, Texas
Study site
Baton Rouge, Louisiana
Study site
Bedford, Texas
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Carmichael, California
Study site
Clearwater, Florida
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
East Lansing, Michigan
Study site
Evansville, Indiana
Study site
Fresno, California
Study site
Garden Grove, California
Study site
Greenville, North Carolina
Study site
Hyannis, Massachusetts
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Lake Charles, Louisiana
Study site
Louisville, Kentucky
Study site
Mandeville, Louisiana
Study site
Meridian, Idaho
Study site
Metairie, Louisiana
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Newburgh, Indiana
Study site
Odessa, Texas
Study site
Oklahoma City, Oklahoma
Study site
Oldsmar, Florida
Study site
Omaha, Nebraska
Study site
Phoenix, Arizona
Study site
Pismo Beach, California
Study site
Port Orange, Florida
Study site
Prairie Village, Kansas
Study site
Raleigh, North Carolina
Study site
Roanoke, Virginia
Study site
Rockville, Maryland
Study site
Roseville, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Spokane, Washington
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Topeka, Kansas
Study site
Tucson, Arizona
Study site
Valparaiso, Indiana
Study site
Watertown, Massachusetts
Study site
West Des Moines, Iowa
Study site
West Jordan, Utah
Study site
Williamsville, New York
Study site
Woodstock, Georgia
Canada16 sites
Study site
Brampton, Ontario
Study site
Burnaby, British Columbia
Study site
Cambridge, Ontario
Study site
Greater Sudbury, Ontario
Study site
Kamloops, British Columbia
Study site
Kelowna, British Columbia
Study site
London, Ontario
Study site
Mississauga, Ontario
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Penticton, British Columbia
Study site
Québec, Quebec
Study site
Sarnia, Ontario
Study site
Sherbrooke, Quebec
Study site
St. John's, Newfoundland and Labrador
Study site
Toronto, Ontario
Poland6 sites
Study site
Bialystok
Study site
Elblag
Study site
Gdynia
Study site
Lublin
Study site
Torun
Study site
Warsaw
About this study
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
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.
Read the 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
- Being tested
- JNJ-42160443, Placebo
- Keywords
- Moderate to severe, osteoarthritis-related pain, Osteoarthritis-related pain, Moderate to severe chronic pain, JNJ-42160443
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42160443Drug
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-42160443Drug
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).
JNJ-42160443Drug
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).
PlaceboDrug
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.
JNJ-42160443Drug
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-42160443Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42160443 1mg every 4 weeks | Experimental | Not described Receives: Drug: JNJ-42160443 |
| JNJ-42160443 3mg every 4 weeks | Experimental | Not described Receives: Drug: JNJ-42160443 |
| JNJ-42160443 3mg every 8 weeks | Experimental | Not described Receives: Drug: JNJ-42160443 |
| JNJ-42160443 6mg every 8 weeks | Experimental | Not described Receives: Drug: JNJ-42160443 |
| JNJ-42160443 10mg every 8 weeks | Experimental | Not described Receives: Drug: JNJ-42160443 |
| Matching placebo every 4 or 8 weeks | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the average osteoarthritis-related pain intensity score
Measured: At the end of the 12-week double-blind efficacy phase
Secondary outcomes (4)
Change from baseline in average OA-related pain intensity scores
Measured: 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
Measured: 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
Measured: At the end of the 12-week double-blind efficacy phase
Changes in PGA scores
Measured: At the end of the 12-week double-blind efficacy phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study start16 Sep 2009
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Why it stopped: Logistic reasons associated with the FDA-imposed clinical hold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973141
- Sponsor's protocol ID
- CR016471
- Other IDs
- 42160443PAI2004, 2009-009856-19, 2009
- Status last verified
- Mar 2020
- First submitted
- 4 Sep 2009
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
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.
PubMed 27748055
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00973141
- Acronym / sponsor ID
- CR016471
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic reasons associated with the FDA-imposed clinical hold.
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2009 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| JNJ-42160443 1mg every 4 weeks | Experimental | Drug: JNJ-42160443 |
| JNJ-42160443 3mg every 4 weeks | Experimental | Drug: JNJ-42160443 |
| JNJ-42160443 3mg every 8 weeks | Experimental | Drug: JNJ-42160443 |
| JNJ-42160443 6mg every 8 weeks | Experimental | Drug: JNJ-42160443 |
| JNJ-42160443 10mg every 8 weeks | Experimental | Drug: JNJ-42160443 |
| Matching placebo every 4 or 8 weeks | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-42160443Type=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 1mg every 4 weeks |
| JNJ-42160443Type=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 10mg every 8 weeks |
| JNJ-42160443Type=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 3mg every 8 weeks |
| PlaceboForm=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks. | Drug | Matching placebo every 4 or 8 weeks |
| JNJ-42160443Type=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 3mg every 4 weeks |
| JNJ-42160443Type=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). | Drug | JNJ-42160443 6mg every 8 weeks |
Primary outcome
Change from baseline in the average osteoarthritis-related pain intensity score
Time frame: At the end of the 12-week double-blind efficacy phase
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Logistic reasons associated with the FDA-imposed clinical hold.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 27748055Sanga 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.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
77 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-42160443 in people with Osteoarthritis and Osteoarthritis, Hip, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 77 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Canada, Poland, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Logistic reasons associated with the FDA-imposed clinical hold.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the average osteoarthritis-related pain intensity score (time frame: At the end of the 12-week double-blind efficacy phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00973141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.