OsteoarthritisPhase 2NCT00394563
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
A Phase 2 study testing RN624 (PF-04383119) in people with Osteoarthritis, run by Pfizer at 48 sites in United States.
Trial summary
The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- RN624 (PF-04383119)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 48 sitesUnited States
- Study dates
- Mar 2006to Oct 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).
- Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
Who cannot join
- History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21224-6821
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Charlotte, North Carolina, 28210-8503
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Charlottesville, Virginia, 22911
Pfizer Investigational Site
Columbus, Ohio, 43212
Pfizer Investigational Site
Cypress, California, 90630
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Greensboro, North Carolina, 27401
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Las Vegas, Nevada, 89123
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Merrillville, Indiana, 46410
Pfizer Investigational Site
Midvale, Utah, 84047
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Sacremento, California, 95817
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Stamford, Connecticut, 06905
Pfizer Investigational Site
Tampa, Florida, 33614-7118
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Worcester, Massachusetts, 01610
Pfizer Investigational Site
Yakima, Washington, 98902
Pfizer Investigational Site
Zanesville, Ohio, 43701
About this study
Official title: A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee
The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.
- Conditions
- Osteoarthritis
- Being tested
- RN624 (PF-04383119), placebo
- Keywords
- osteoarthritis monoclonal antibody
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN624 (PF-04383119)Drug
10 mcg/kg
RN624 (PF-04383119)Drug
25 mcg/kg
RN624 (PF-04383119)Drug
50 mcg/kg
RN624 (PF-04383119)Drug
100 mcg/kg
RN624 (PF-04383119)Drug
200 mcg/kg
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | monoclonal antibody Receives: Drug: RN624 (PF-04383119) |
| 2 | Experimental | Not described Receives: Drug: RN624 (PF-04383119) |
| 3 | Experimental | Not described Receives: Drug: RN624 (PF-04383119) |
| 4 | Experimental | Not described Receives: Drug: RN624 (PF-04383119) |
| 5 | Experimental | Not described Receives: Drug: RN624 (PF-04383119) |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking knee pain scores
Measured: Day 112
Secondary outcomes (3)
Overall knee pain scores
Measured: Day 112
Incidence of adverse events and serious adverse events
Measured: Day 112
WOMAC
Measured: Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394563
- Sponsor's protocol ID
- A4091008
- Other IDs
- RN624-CL006
- Status last verified
- Oct 2009
- First submitted
- 30 Oct 2006
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, Brown MT. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med. 2010 Oct 14;363(16):1521-31. doi: 10.1056/NEJMoa0901510. Epub 2010 Sep 29.
PubMed 20942668
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00394563
- Acronym / sponsor ID
- A4091008
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Nov 2006 (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 look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RN624 (PF-04383119)monoclonal antibody |
| 2 | Experimental | Drug: RN624 (PF-04383119) |
| 3 | Experimental | Drug: RN624 (PF-04383119) |
| 4 | Experimental | Drug: RN624 (PF-04383119) |
| 5 | Experimental | Drug: RN624 (PF-04383119) |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).
- Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
Key exclusion criteria (1 listed)
- History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders
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 |
|---|---|---|
| RN624 (PF-04383119)10 mcg/kg | Drug | 1 |
| RN624 (PF-04383119)25 mcg/kg | Drug | 2 |
| RN624 (PF-04383119)50 mcg/kg | Drug | 3 |
| RN624 (PF-04383119)100 mcg/kg | Drug | 4 |
| RN624 (PF-04383119)200 mcg/kg | Drug | 5 |
| placebo | Drug | placebo |
Primary outcome
Walking knee pain scores
Time frame: Day 112
3 secondary outcomes
Overall knee pain scores
Time frame: Day 112
Incidence of adverse events and serious adverse events
Time frame: Day 112
WOMAC
Time frame: Day 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Derived from this study: PubMed 20942668Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, Brown MT. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med. 2010 Oct 14;363(16):1521-31. doi: 10.1056/NEJMoa0901510. Epub 2010 Sep 29.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RN624 (PF-04383119) in people with Osteoarthritis, run by Pfizer at 48 sites in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Walking knee pain scores (time frame: Day 112). 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 NCT00394563, 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 12 Oct 2009.