Clinical trial NCT00399490: Open-label Extension Study Of RN624
Official title: OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
OA Knee Pain
Arthritis
Keywords: Monoclonal antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 287
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Study RN624-CL006

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 12 weeks after last dose of study drug
Secondary outcomes:
measure: 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
timeFrame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: 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
timeFrame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: 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
timeFrame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: 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
timeFrame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
timeFrame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: Number of Participants With Response to Participant Satisfaction Questionnaire
timeFrame: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
timeFrame: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: Percentage of Participants Who Discontinued the Study
timeFrame: A4091009: Baseline up to 12 weeks after last dose of study drug
measure: Median Time in Study A4091009
timeFrame: A4091009: Baseline up to 12 weeks after last dose of study drug
Other outcomes:
measure: 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
timeFrame: 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)
Locations:
city: Birmingham
country: United States
facility: BrookWood Internal Medicine
state: Alabama
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center, LLC
state: Arizona
city: Anaheim
country: United States
facility: Imaging Centers of Anaheim
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Research
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Stamford
country: United States
facility: David M. Radin, MD
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Tampa
country: United States
facility: Habana Hospital Pharmacy
state: Florida
city: Honolulu
country: United States
facility: Covance Clinical Research Unit, Inc. Honolulu
state: Hawaii
city: Boise
country: United States
facility: Covance Boise
state: Idaho
city: Merrillville
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Office of David Neustadt, PSL
state: Kentucky
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, P.C.
state: Missouri
city: Omaha
country: United States
facility: Quality Clincal Research
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Greensboro
country: United States
facility: Sports Medicine and Orthopaedics Center
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates Incorporated
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Austin
country: United States
facility: Office of Walter F. Chase, MD, PA
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Rheumatology Associates of South Texas
state: Texas
city: San Antonio
country: United States
facility: South Texas Radiology Imaging Center
state: Texas
city: Midvale
country: United States
facility: Pivotal Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Yakima
country: United States
facility: Clinical Trials Northwest
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.