Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2006

Geographic Reach

1 country

48 active sites

Status

completed

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

1.6 years study duration

Study Start

First participant enrolled

March 1, 2006

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed

Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

1.6 years

First QC Date

October 30, 2006

Last Update Submit

October 7, 2009

Conditions

Osteoarthritis

Keywords

osteoarthritis monoclonal antibody

Outcome Measures

Primary Outcomes (1)

Walking knee pain scores
Day 112

Secondary Outcomes (3)

Overall knee pain scores
Day 112
Incidence of adverse events and serious adverse events
Day 112
WOMAC
Day 112

Study Arms (6)

1

EXPERIMENTAL

monoclonal antibody

Drug: RN624 (PF-04383119)

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

Interventions

RN624 (PF-04383119)DRUG

10 mcg/kg

placeboDRUG

placebo

Eligibility Criteria

Age40 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (48)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

Location

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Cypress, California, 90630, United States

Location

Pfizer Investigational Site

National City, California, 91950, United States

Location

Pfizer Investigational Site

Sacremento, California, 95817, United States

Location

Pfizer Investigational Site

Stamford, Connecticut, 06905, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32114, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33614-7118, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30328, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96813, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96814, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83704, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47713, United States

Location

Pfizer Investigational Site

Merrillville, Indiana, 46410, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21224-6821, United States

Location

Pfizer Investigational Site

Wheaton, Maryland, 20902, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01610, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64114, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63141, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68114, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89123, United States

Location

Pfizer Investigational Site

Reno, Nevada, 89502, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210-8503, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

Greensboro, North Carolina, 27401, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43212, United States

Location

Pfizer Investigational Site

Zanesville, Ohio, 43701, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Bethlehem, Pennsylvania, 18015, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Greer, South Carolina, 29651, United States

Location

Pfizer Investigational Site

Jackson, Tennessee, 38305, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Location

Pfizer Investigational Site

Midvale, Utah, 84047, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, 22911, United States

Location

Pfizer Investigational Site

Yakima, Washington, 98902, United States

Location

Related Publications (1)

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.
PMID: 20942668DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

tanezumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 30, 2006

First Posted

November 1, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

US(48)

A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

1

2

3

4

5

placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

1

2

3

4

5

placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations