Open-label Extension Study Of RN624

OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.

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.

Study Overview

• Status: Completed
• Conditions: Arthritis; Osteoarthritis; OA Knee Pain
• Intervention / Treatment: Drug: RN624 (PF-04383119)

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research
    • Birmingham, Alabama, United States, 35209
      • BrookWood Internal Medicine
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center, LLC
  • California
    • Anaheim, California, United States, 92801
      • Imaging Centers of Anaheim
    • Anaheim, California, United States, 92801
      • Orange County Clinical Research
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
    • Stamford, Connecticut, United States, 06905
      • David M. Radin, MD
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Unit, Inc
    • Ocala, Florida, United States, 34474-7455
      • Ocala Rheumatology Research Center
    • Tampa, Florida, United States, 33614-7118
      • Tampa Medical Group, PA
    • Tampa, Florida, United States, 33614
      • Habana Hospital Pharmacy
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Covance Clinical Research Unit, Inc. Honolulu
  • Idaho
    • Boise, Idaho, United States, 83704
      • Covance Boise
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Northwest Indiana Center for Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Office of David Neustadt, PSL
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research, P.C.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clincal Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Greensboro, North Carolina, United States, 27401
      • Sports Medicine and Orthopaedics Center
  • Ohio
    • Zanesville, Ohio, United States, 43701
      • Pharmacotherapy Research Associates Incorporated
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
  • Texas
    • Austin, Texas, United States, 78705
      • Office of Walter F. Chase, MD, PA
    • San Antonio, Texas, United States, 78217
      • Radiant Research San Antonio Northeast
    • San Antonio, Texas, United States, 78217
      • Radiant Research - San Antonio
    • San Antonio, Texas, United States, 78217
      • South Texas Radiology Imaging Center
    • San Antonio, Texas, United States, 78217
      • Rheumatology Associates of South Texas
  • Utah
    • Midvale, Utah, United States, 84047
      • Pivotal Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
  • Washington
    • Yakima, Washington, United States, 98902
      • Clinical Trials Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: RN624 (PF-04383119); 50 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.	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	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.	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	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.	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	Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.	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	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Number of Participants With Response to Participant Satisfaction Questionnaire	Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
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	SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Percentage of Participants Who Discontinued the Study		A4091009: Baseline up to 12 weeks after last dose of study drug
Median Time in Study A4091009	Median time of participation in the study for all the participants was evaluated.	A4091009: Baseline up to 12 weeks after last dose of study drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall test, ranged: 0 (no memory) to 12 (best memory), where higher scores indicated better memory.	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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2006
• Primary Completion (ACTUAL): February 11, 2008
• Study Completion (ACTUAL): February 11, 2008

Study Registration Dates

• First Submitted: November 14, 2006
• First Submitted That Met QC Criteria: November 14, 2006
• First Posted (ESTIMATE): November 15, 2006

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Monoclonal antibody
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091009; RN624-CL007 (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.