NCT00399490

Brief Summary

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

36 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

Study Start

First participant enrolled

September 15, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2008

Completed
13 years until next milestone

Results Posted

Study results publicly available

February 2, 2021

Completed
Last Updated

February 2, 2021

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 14, 2006

Results QC Date

January 11, 2021

Last Update Submit

January 11, 2021

Conditions

OsteoarthritisOA Knee PainArthritis

Keywords

Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.

    Baseline up to 12 weeks after last dose of study drug

Secondary Outcomes (9)

  • Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  • Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  • Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  • Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  • Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  • +4 more secondary outcomes

Other Outcomes (1)

  • Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study

    A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug)

Study Arms (1)

1

EXPERIMENTAL
Drug: RN624 (PF-04383119)

Interventions

RN624 (PF-04383119)DRUG

50 mcg/kg

1

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in Study RN624-CL006

You may not qualify if:

  • The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
  • Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

BrookWood Internal Medicine

Birmingham, Alabama, 35209, United States

Location

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Arizona Research Center, LLC

Phoenix, Arizona, 85023, United States

Location

Imaging Centers of Anaheim

Anaheim, California, 92801, United States

Location

Orange County Clinical Research

Anaheim, California, 92801, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

David M. Radin, MD

Stamford, Connecticut, 06905, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Covance Clinical Research Unit, Inc

Daytona Beach, Florida, 32117, United States

Location

Ocala Rheumatology Research Center

Ocala, Florida, 34474-7455, United States

Location

Tampa Medical Group, PA

Tampa, Florida, 33614-7118, United States

Location

Habana Hospital Pharmacy

Tampa, Florida, 33614, United States

Location

Covance Clinical Research Unit, Inc. Honolulu

Honolulu, Hawaii, 96813, United States

Location

Covance Boise

Boise, Idaho, 83704, United States

Location

Northwest Indiana Center for Clinical Research

Merrillville, Indiana, 46410, United States

Location

Office of David Neustadt, PSL

Louisville, Kentucky, 40202, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

Quality Clincal Research

Omaha, Nebraska, 68114, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Sports Medicine and Orthopaedics Center

Greensboro, North Carolina, 27401, United States

Location

Pharmquest

Greensboro, North Carolina, 27408, United States

Location

Pharmacotherapy Research Associates Incorporated

Zanesville, Ohio, 43701, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Office of Walter F. Chase, MD, PA

Austin, Texas, 78705, United States

Location

Radiant Research - San Antonio

San Antonio, Texas, 78217, United States

Location

Radiant Research San Antonio Northeast

San Antonio, Texas, 78217, United States

Location

Rheumatology Associates of South Texas

San Antonio, Texas, 78217, United States

Location

South Texas Radiology Imaging Center

San Antonio, Texas, 78217, United States

Location

Pivotal Research

Midvale, Utah, 84047, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Clinical Trials Northwest

Yakima, Washington, 98902, United States

Location

Related Publications (1)

  • Schnitzer TJ, Lane NE, Birbara C, Smith MD, Simpson SL, Brown MT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage. 2011 Jun;19(6):639-46. doi: 10.1016/j.joca.2011.01.009. Epub 2011 Jan 18.

    PMID: 21251985DERIVED

Related Links

MeSH Terms

Conditions

OsteoarthritisArthritis

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

Data for rescue medication was recorded on the concomitant medication page of the case report form (CRF) as 'pro re nata (as needed)' rather than 'as pill counts'; hence total daily dose of rescue medication received was not recorded.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

September 15, 2006

Primary Completion

February 11, 2008

Study Completion

February 11, 2008

Last Updated

February 2, 2021

Results First Posted

February 2, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

US(36)